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A Multicenter Study to Determine the Depth and Duration of Hepatitis B Surface Antigen (HBsAg) Reduction After Single or Multiple Doses of ARC-520, in Combination With Entecavir in Patients With Chronic Hepatitis B Virus (HBV) Infection

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ClinicalTrials.gov Identifier: NCT02065336
Recruitment Status : Terminated (Company decision to discontinue trial)
First Posted : February 19, 2014
Results First Posted : July 5, 2019
Last Update Posted : July 5, 2019
Sponsor:
Collaborator:
ICON Clinical Research
Information provided by (Responsible Party):
Arrowhead Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Hepatitis B, Chronic
Interventions Drug: ARC-520
Drug: Placebo
Drug: entecavir
Drug: chlorpheniramine
Enrollment 58
Recruitment Details  
Pre-assignment Details No patients were enrolled in Cohorts 8, 11, or 12. Cohort 9 (n=2) and Cohort 10 (n=8) enrolled participants who previously completed treatment in other cohorts.
Arm/Group Title ARC-520 Cohort 1 ARC-520 Cohort 2 ARC-520 Cohort 3 ARC-520 Cohort 4 ARC-520 Cohort 5 ARC-520 Cohort 6 ARC-520 Cohort 7 Placebo Normal Saline Cohorts 1-5 ARC-520 Cohort 9 ARC-520 Cohort 10
Hide Arm/Group Description a single intravenous (IV) dose of double-blind ARC-520 Injection 1.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection a single IV dose of double-blind ARC-520 Injection 2.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection a single IV dose of double-blind ARC-520 Injection 3.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-positive immune active chronic HBV infection two IV doses of open-label ARC-520 2.0 mg/kg administered to participants with HBeAg-positive immune active chronic HBV a single IV dose of open-label ARC-520 4.0 mg/kg administered to treatment-naïve, HBeAg-negative or -positive participants with chronic hepatitis B (CHB) a single IV dose of double-blind normal saline in combination with entecavir administered to participants with HBeAg-negative or -positive immune active chronic HBV infection open-label multi-dose extension cohort: multiple IV doses of open-label ARC-520 (4.0 mg/kg Q6 weeks or Q8 weeks) administered to HBeAg-positive participants with CHB receiving chronic entecavir therapy who completed Cohorts 5 or 6 open-label multi-dose extension cohort: multiple IV doses of open-label ARC-520 (4.0 mg/kg Q4 weeks) administered to a mixed cohort (HBeAg-negative and -positive participants) who were naïve (within the last 6 months) to entecavir treatment and completed Cohort 7
Period Title: Main Study
Started 6 6 6 6 6 6 12 10 0 0
Completed 6 6 6 6 6 6 12 10 0 0
Not Completed 0 0 0 0 0 0 0 0 0 0
Period Title: Extension Phase
Started 0 0 0 0 0 0 0 0 2 8
Completed 0 0 0 0 0 0 0 0 0 0
Not Completed 0 0 0 0 0 0 0 0 2 8
Reason Not Completed
Study Terminated by Sponsor             0             0             0             0             0             0             0             0             2             8
Arm/Group Title ARC-520 Cohort 1 ARC-520 Cohort 2 ARC-520 Cohort 3 ARC-520 Cohort 4 ARC-520 Cohort 5 ARC-520 Cohort 6 ARC-520 Cohort 7 Placebo Normal Saline Cohorts 1-5 Total
Hide Arm/Group Description a single IV dose of double-blind ARC-520 Injection 1.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection a single IV dose of double-blind ARC-520 Injection 2.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection a single IV dose of double-blind ARC-520 Injection 3.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-positive immune active chronic HBV infection two IV doses of open-label ARC-520 2.0 mg/kg administered to participants with HBeAg-positive immune active chronic HBV a single IV dose of open-label ARC-520 4.0 mg/kg administered to treatment-naïve, HBeAg-negative or -positive participants with chronic hepatitis B (CHB) a single IV dose of double-blind normal saline in combination with entecavir administered to participants with HBeAg-negative or -positive immune active chronic HBV infection Total of all reporting groups
Overall Number of Baseline Participants 6 6 6 6 6 6 12 10 58
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 12 participants 10 participants 58 participants
49.0  (8.22) 43.0  (4.15) 42.0  (1.79) 39.8  (2.04) 39.5  (7.23) 33.3  (4.23) 39.8  (10.12) 44.4  (9.09) 41.4  (7.94)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 12 participants 10 participants 58 participants
Female
2
  33.3%
2
  33.3%
3
  50.0%
1
  16.7%
2
  33.3%
3
  50.0%
5
  41.7%
2
  20.0%
20
  34.5%
Male
4
  66.7%
4
  66.7%
3
  50.0%
5
  83.3%
4
  66.7%
3
  50.0%
7
  58.3%
8
  80.0%
38
  65.5%
1.Primary Outcome
Title Change From Baseline Over Time in Quantitative Hepatitis B Surface Antigen (HBsAG)
Hide Description [Not Specified]
Time Frame Baseline, through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 253 Cohort 10)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamic (PD) Population: all participants who received at least 1 dose of study drug and had evaluable data from at least one postdose PD assessment according to the treatment the participants were assigned.
Arm/Group Title ARC-520 Cohort 1 ARC-520 Cohort 2 ARC-520 Cohort 3 ARC-520 Cohort 4 ARC-520 Cohort 5 ARC-520 Cohort 6 ARC-520 Cohort 7 Placebo Normal Saline Cohorts 1-5 ARC-520 Cohort 9 ARC-520 Cohort 10
Hide Arm/Group Description:
a single IV dose of double-blind ARC-520 Injection 1.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
a single IV dose of double-blind ARC-520 Injection 2.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
a single IV dose of double-blind ARC-520 Injection 3.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-positive immune active chronic HBV infection
two IV doses of open-label ARC-520 2.0 mg/kg administered to participants with HBeAg-positive immune active chronic HBV
a single IV dose of open-label ARC-520 4.0 mg/kg administered to treatment-naïve, HBeAg-negative or -positive participants with chronic hepatitis B (CHB)
a single IV dose of double-blind normal saline in combination with entecavir administered to participants with HBeAg-negative or -positive immune active chronic HBV infection
open-label multi-dose extension cohort: multiple IV doses of open-label ARC-520 (4.0 mg/kg Q6 weeks or Q8 weeks) administered to HBeAg-positive participants with CHB receiving chronic entecavir therapy who completed Cohorts 5 or 6
open-label multi-dose extension cohort: multiple IV doses of open-label ARC-520 (4.0 mg/kg Q4 weeks) administered to a mixed cohort (HBeAg-negative and -positive participants) who were naïve (within the last 6 months) to entecavir treatment and completed Cohort 7
Overall Number of Participants Analyzed 6 6 6 6 6 6 12 10 0 8
Mean (Standard Deviation)
Unit of Measure: IU/mL
Day 1 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 8 participants
-19222  (27217)
Day 3 Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 12 participants 10 participants 0 participants 0 participants
-554.8  (861.86) -1194.0  (2083.72) -1003.6  (949.36) -1501.0  (1930.12) -1664.7  (2375.62) -948.0  (1016.31) -12401.1  (17661.02) 43.3  (267.60)
Day 8 Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 12 participants 10 participants 0 participants 0 participants
-928.1  (1285.26) -2179.2  (3170.68) -884.3  (1296.49) -2591.2  (3304.72) -1789.8  (2101.23) -1344.0  (1319.66) -20123.8  (29795.99) 42.2  (568.32)
Day 15 Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 0 participants 12 participants 10 participants 0 participants 0 participants
-1055.1  (1900.89) -2260.8  (4022.82) -470.8  (2025.31) -3069.0  (3923.45) -1672.8  (1892.73) -22915.6  (34381.59) 236.6  (321.17)
Day 22 Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 12 participants 10 participants 0 participants 0 participants
-1225.4  (1967.15) -2266.2  (3868.90) -204.3  (2077.12) -2978.8  (3536.73) -1951.7  (2819.85) -1553.7  (1596.05) -23872.7  (35753.39) 115.1  (594.38)
Day 29 Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 12 participants 10 participants 0 participants 8 participants
-579.1  (352.71) -1826.3  (2618.78) 93.3  (2425.68) -2972.8  (3506.01) -1964.3  (2501.62) -1532.3  (1500.40) -24148.3  (36256.02) 168.8  (460.59) -22617  (32653)
Day 43 Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 12 participants 10 participants 0 participants 0 participants
-1020.1  (1252.98) -1288.8  (1498.60) -1471.8  (1625.30) -3219.8  (3601.70) -1939.7  (2277.79) -1566.8  (1290.46) -23932.0  (35929.80) 58.3  (411.60)
Day 57 Number Analyzed 0 participants 6 participants 6 participants 6 participants 6 participants 6 participants 12 participants 10 participants 0 participants 8 participants
-1056.7  (773.69) -2330.1  (1676.50) -2813.0  (2665.97) -1536.0  (1373.46) -1370.7  (872.64) -22658.4  (34292.84) 156.1  (527.40) -22840  (32239)
Day 85 Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 12 participants 10 participants 0 participants 8 participants
-670.1  (1825.99) -542.8  (1815.34) -2119.3  (1717.17) -926.3  (1406.29) -537.5  (1901.16) -791.0  (457.04) -20827.2  (31753.76) 225.4  (393.81) -23305  (32455)
Day 113 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 8 participants
-23205  (32362)
Day 141 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 8 participants
-23182  (32379)
Day 169 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 7 participants
-26481  (33649)
Day 197 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 6 participants
-30234  (34097)
Day 225 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 3 participants
-1249  (1273)
Day 253 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 2 participants
-643  (905)
2.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Hide Description An adverse event (AE) is any untoward medical occurrence which does not necessarily have a causal relationship with this treatment. An SAE is any AE that: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is a medically important event or reaction.Events were categorized as mild, moderate or severe. TEAEs were defined as all AEs starting or worsening after commencement of treatment with investigational product. A treatment-related TEAE was one whose relationship to treatment was noted as unlikely, possibly, or probably related.
Time Frame through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants who received any amount of study drug or placebo, and had at least 1 postdose safety assessment. Data for Cohort 9 was not analyzed or summarized due to limited enrollment.
Arm/Group Title ARC-520 Cohort 1 ARC-520 Cohort 2 ARC-520 Cohort 3 ARC-520 Cohort 4 ARC-520 Cohort 5 ARC-520 Cohort 6 ARC-520 Cohort 7 ARC-520 Cohort 9 ARC-520 Cohort 10 Placebo Normal Saline Cohorts 1-5
Hide Arm/Group Description:
a single IV dose of double-blind ARC-520 Injection 1.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
a single IV dose of double-blind ARC-520 Injection 2.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
a single IV dose of double-blind ARC-520 Injection 3.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-positive immune active chronic HBV infection
two IV doses of open-label ARC-520 2.0 mg/kg administered to participants with HBeAg-positive immune active chronic HBV
a single IV dose of open-label ARC-520 4.0 mg/kg administered to treatment-naïve, HBeAg-negative or -positive participants with CHB
open-label multi-dose extension cohort: multiple IV doses of open-label ARC-520 (4.0 mg/kg Q6 weeks or Q8 weeks) administered to HBeAg-positive participants with CHB receiving chronic entecavir therapy who completed Cohorts 5 or 6
open-label multi-dose extension cohort: multiple IV doses of open-label ARC-520 (4.0 mg/kg Q4 weeks) administered to a mixed cohort (HBeAg-negative and -positive participants) who were naïve (within the last 6 months) to entecavir treatment and completed Cohort 7
a single IV dose of double-blind normal saline in combination with entecavir administered to participants with HBeAg-negative or -positive immune active chronic HBV infection
Overall Number of Participants Analyzed 6 6 6 6 6 6 12 2 8 10
Measure Type: Count of Participants
Unit of Measure: Participants
Any TEAE
1
  16.7%
4
  66.7%
1
  16.7%
0
   0.0%
1
  16.7%
1
  16.7%
1
   8.3%
1
  50.0%
7
  87.5%
0
   0.0%
Any mild TEAE
1
  16.7%
3
  50.0%
1
  16.7%
0
   0.0%
1
  16.7%
1
  16.7%
1
   8.3%
1
  50.0%
7
  87.5%
0
   0.0%
Any moderate TEAE
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Any severe TEAE
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Any TEAE related to study drug
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
4
  50.0%
0
   0.0%
Any TEAE leading to discontinuation of treatment
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Any SAE
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Any SAE related to study drug
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Any life-threatening SAE
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Any SAE leading to death
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3.Secondary Outcome
Title Number of Participants With Negative Bee Venom Allergy Test Results at Baseline, Day 29, and Day 85
Hide Description Bee venom allergy tests were used to assess immunoglobulin E (IgE) in Cohorts 1-7. Analysis values less than 0.35 kU/L were taken as negative.
Time Frame Baseline, Day 29, Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants who received any amount of study drug or placebo, and had at least 1 postdose safety assessment.
Arm/Group Title ARC-520 Cohort 1 ARC-520 Cohort 2 ARC-520 Cohort 3 ARC-520 Cohort 4 ARC-520 Cohort 5 ARC-520 Cohort 6 ARC-520 Cohort 7 Placebo Normal Saline Cohorts 1-5
Hide Arm/Group Description:
a single IV dose of double-blind ARC-520 Injection 1.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
a single IV dose of double-blind ARC-520 Injection 2.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
a single IV dose of double-blind ARC-520 Injection 3.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-positive immune active chronic HBV infection
two IV doses of open-label ARC-520 2.0 mg/kg administered to participants with HBeAg-positive immune-active chronic HBV
a single IV dose of open-label ARC-520 4.0 mg/kg administered to treatment-naïve, HBeAg-negative or -positive participants with CHB
a single IV dose of double-blind normal saline in combination with entecavir administered to participants with HBeAg-negative or -positive immune active chronic HBV infection
Overall Number of Participants Analyzed 6 6 6 6 6 6 12 10
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
12
 100.0%
10
 100.0%
Day 29
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
11
  91.7%
10
 100.0%
Day 85
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
11
  91.7%
10
 100.0%
4.Secondary Outcome
Title Change From Baseline in Entecavir Plasma Trough Concentration, Cohorts 1-7
Hide Description [Not Specified]
Time Frame Baseline, Days 1, 2, 3, 8, 15, 22, 29
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) Population: all participants who received at least 1 dose of study drug and had evaluable PK data.
Arm/Group Title ARC-520 Cohort 1 ARC-520 Cohort 2 ARC-520 Cohort 3 ARC-520 Cohorts 4 and 5 ARC-520 Cohort 6 ARC-520 Cohort 7 Placebo Normal Saline Cohorts 1-5
Hide Arm/Group Description:
a single IV dose of double-blind ARC-520 Injection 1.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
a single IV dose of double-blind ARC-520 Injection 2.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
a single IV dose of double-blind ARC-520 Injection 3.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection or participants with HBeAg-positive immune active chronic HBV infection
two IV doses of open-label ARC-520 2.0 mg/kg administered to participants with HBeAg-positive immune-active chronic HBV
a single IV dose of open-label ARC-520 4.0 mg/kg administered to treatment-naïve, HBeAg-negative or -positive participants with CHB
a single IV dose of double-blind normal saline in combination with entecavir administered to participants with HBeAg-negative or -positive immune active chronic HBV infection
Overall Number of Participants Analyzed 6 6 6 12 6 12 10
Mean (Standard Deviation)
Unit of Measure: ng/mL
Day 1 0  (0) 0  (0) 0  (0) 0  (0) 0  (0) 0  (0) 0  (0)
Day 2 0.06  (0.05) 0.06  (0.08) 0.13  (0.08) 0.12  (0.10) -0.91  (1.59) 0.16  (0.04) -0.31  (0.89)
Day 3 -0.02  (0.02) -0.06  (0.09) -0.06  (0.06) 0.12  (0.63) -1.04  (1.58) 0.15  (0.03) -0.29  (0.88)
Day 8 -0.01  (0.07) -0.09  (0.08) -0.09  (0.13) -0.03  (0.18) -1.01  (1.60) 0.45  (0.76) -0.30  (0.90)
Day 15 0.01  (0.05) -0.03  (0.12) -0.03  (0.06) 0.00  (0.18) -1.01  (1.63) 0.32  (0.11) -0.10  (1.14)
Day 22 0.04  (0.06) -0.02  (0.14) -0.03  (0.09) 0.00  (0.13) -1.00  (1.58) 0.33  (0.11) -0.30  (0.89)
Day 29 0.00  (0.06) -0.01  (0.11) 0.01  (0.07) 0.00  (0.15) -1.00  (1.61) 0.36  (0.11) -0.30  (0.89)
5.Secondary Outcome
Title Pharmacokinetics of ARC-520 Product Constituents AD0009 and AD0010: Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24), Cohorts 1-5
Hide Description [Not Specified]
Time Frame Day 1 predose, immediately prior to the end of infusion, 0.5, 1, 3, 6, 24, and 48 hours postdose
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PK Population: all participants who received at least 1 dose of study drug and had evaluable PK data.
Arm/Group Title ARC-520 Cohort 1 ARC-520 Cohort 2 ARC-520 Cohort 3 ARC-520 Cohort 4 ARC-520 Cohort 5
Hide Arm/Group Description:
a single IV dose of double-blind ARC-520 Injection 1.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
a single IV dose of double-blind ARC-520 Injection 2.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
a single IV dose of double-blind ARC-520 Injection 3.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-positive immune active chronic HBV infection
Overall Number of Participants Analyzed 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: µg*hr/mL
AD0009 Number Analyzed 6 participants 5 participants 6 participants 6 participants 6 participants
79.1  (8.28) 185  (61.2) 212  (34.7) 318  (82.3) 349  (45.2)
AD0010 Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants
93.0  (9.11) 190  (43.2) 301  (43.9) 370  (80.5) 412  (47.5)
6.Secondary Outcome
Title Pharmacokinetics of ARC-520 of ARC-520 Product Constituents AD0009 and AD0010: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Quantifiable Plasma Concentration (AUClast), Cohorts 1-5
Hide Description [Not Specified]
Time Frame Day 1 predose, immediately prior to the end of infusion, 0.5, 1, 3, 6, 24, and 48 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: all participants who received at least 1 dose of study drug and had evaluable PK data.
Arm/Group Title ARC-520 Cohort 1 ARC-520 Cohort 2 ARC-520 Cohort 3 ARC-520 Cohort 4 ARC-520 Cohort 5
Hide Arm/Group Description:
a single IV dose of double-blind ARC-520 Injection 1.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
a single IV dose of double-blind ARC-520 Injection 2.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
a single IV dose of double-blind ARC-520 Injection 3.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-positive immune active chronic HBV infection
Overall Number of Participants Analyzed 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: µg*hr/mL
AD0009 Number Analyzed 6 participants 5 participants 6 participants 6 participants 6 participants
81.4  (9.25) 196  (66.3) 218  (37.1) 326  (87.3) 356  (47.4)
AD0010 Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants
97.6  (9.77) 205  (50.2) 317  (50.7) 385  (88.0) 434  (53.3)
7.Secondary Outcome
Title Pharmacokinetics of ARC-520 Product Constituents AD0009 and AD0010: Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf), Cohorts 1-5 Only
Hide Description [Not Specified]
Time Frame Day 1 predose, immediately prior to the end of infusion, 0.5, 1, 3, 6, 24, and 48 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: all participants who received at least 1 dose of study drug and had evaluable PK data.
Arm/Group Title ARC-520 Cohort 1 ARC-520 Cohort 2 ARC-520 Cohort 3 ARC-520 Cohort 4 ARC-520 Cohort 5
Hide Arm/Group Description:
a single IV dose of double-blind ARC-520 Injection 1.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
a single IV dose of double-blind ARC-520 Injection 2.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
a single IV dose of double-blind ARC-520 Injection 3.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-positive immune active chronic HBV infection
Overall Number of Participants Analyzed 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: µg*hr/mL
AD0009 Number Analyzed 6 participants 5 participants 6 participants 6 participants 6 participants
81.4  (9.26) 196  (66.3) 218  (37.2) 326  (87.4) 356  (47.4)
AD0010 Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants
97.8  (9.80) 207  (51.1) 318  (51.2) 386  (88.6) 435  (53.8)
8.Secondary Outcome
Title Pharmacokinetics of ARC-520 Product Constituents AD0009 and AD0010: Maximum Observed Plasma Concentration (Cmax), Cohorts 1-5
Hide Description [Not Specified]
Time Frame Day 1 predose, immediately prior to the end of infusion, 0.5, 1, 3, 6, 24, and 48 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: all participants who received at least 1 dose of study drug and had evaluable PK data.
Arm/Group Title ARC-520 Cohort 1 ARC-520 Cohort 2 ARC-520 Cohort 3 ARC-520 Cohort 4 ARC-520 Cohort 5
Hide Arm/Group Description:
a single IV dose of double-blind ARC-520 Injection 1.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
a single IV dose of double-blind ARC-520 Injection 2.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
a single IV dose of double-blind ARC-520 Injection 3.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-positive immune active chronic HBV infection
Overall Number of Participants Analyzed 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: µg/mL
AD0009 Number Analyzed 6 participants 5 participants 6 participants 6 participants 6 participants
13.7  (2.42) 26.4  (6.84) 33.5  (1.78) 54.8  (9.59) 58.2  (5.88)
AD0010 Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants
12.7  (2.07) 22.5  (2.74) 39.7  (2.60) 50.5  (10.6) 52.4  (6.44)
9.Secondary Outcome
Title Pharmacokinetics of ARC-520 Product Constituents AD0009 and AD0010: Clearance (CL), Cohorts 1-5
Hide Description [Not Specified]
Time Frame Day 1 predose, immediately prior to the end of infusion, 0.5, 1, 3, 6, 24, and 48 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: all participants who received at least 1 dose of study drug and had evaluable PK data.
Arm/Group Title ARC-520 Cohort 1 ARC-520 Cohort 2 ARC-520 Cohort 3 ARC-520 Cohort 4 ARC-520 Cohort 5
Hide Arm/Group Description:
a single IV dose of double-blind ARC-520 Injection 1.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
a single IV dose of double-blind ARC-520 Injection 2.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
a single IV dose of double-blind ARC-520 Injection 3.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-positive immune active chronic HBV infection
Overall Number of Participants Analyzed 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: mL/hr/kg
AD0009 Number Analyzed 6 participants 5 participants 6 participants 6 participants 6 participants
6.21  (0.724) 5.58  (1.84) 7.11  (1.56) 6.47  (1.51) 5.70  (0.781)
AD0010 Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants
5.16  (0.522) 5.08  (1.19) 4.84  (0.952) 5.41  (1.19) 4.65  (0.586)
10.Secondary Outcome
Title Pharmacokinetics of ARC-520 Product Constituents AD0009 and AD0010: Apparent Volume of Distribution During the Terminal Phase (Vz), Cohorts 1-5
Hide Description [Not Specified]
Time Frame Day 1 predose, immediately prior to the end of infusion, 0.5, 1, 3, 6, 24, and 48 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: all participants who received at least 1 dose of study drug and had evaluable PK data.
Arm/Group Title ARC-520 Cohort 1 ARC-520 Cohort 2 ARC-520 Cohort 3 ARC-520 Cohort 4 ARC-520 Cohort 5
Hide Arm/Group Description:
a single IV dose of double-blind ARC-520 Injection 1.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
a single IV dose of double-blind ARC-520 Injection 2.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
a single IV dose of double-blind ARC-520 Injection 3.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-positive immune active chronic HBV infection
Overall Number of Participants Analyzed 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: mL/kg
AD0009 39.5  (4.13) 43.2  (15.8) 45.7  (5.72) 39.0  (7.27) 35.4  (4.06)
AD0010 39.4  (5.01) 46.1  (9.99) 37.1  (2.52) 37.9  (5.83) 36.9  (3.18)
11.Secondary Outcome
Title Pharmacokinetics of ARC-520 Product Constituents AD0009 and AD0010: Volume in Steady State (Vss), Cohorts 1-5
Hide Description [Not Specified]
Time Frame Day 1 predose, immediately prior to the end of infusion, 0.5, 1, 3, 6, 24, and 48 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: all participants who received at least 1 dose of study drug and had evaluable PK data.
Arm/Group Title ARC-520 Cohort 1 ARC-520 Cohort 2 ARC-520 Cohort 3 ARC-520 Cohort 4 ARC-520 Cohort 5
Hide Arm/Group Description:
a single IV dose of double-blind ARC-520 Injection 1.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
a single IV dose of double-blind ARC-520 Injection 2.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
a single IV dose of double-blind ARC-520 Injection 3.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-positive immune active chronic HBV infection
Overall Number of Participants Analyzed 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: mL/kg
AD0009 Number Analyzed 6 participants 5 participants 6 participants 6 participants 6 participants
39.6  (6.05) 45.8  (11.6) 45.3  (3.60) 39.6  (6.31) 35.3  (3.57)
AD0010 Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants
40.7  (6.01) 46.7  (8.22) 38.1  (2.08) 39.8  (6.36) 38.5  (4.21)
12.Secondary Outcome
Title Pharmacokinetics of ARC-520 Product Constituents AD0009 and AD0010: Terminal Elimination Rate Constant (Kel), Cohorts 1-5
Hide Description [Not Specified]
Time Frame Day 1 predose, immediately prior to the end of infusion, 0.5, 1, 3, 6, 24, and 48 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: all participants who received at least 1 dose of study drug and had evaluable PK data.
Arm/Group Title ARC-520 Cohort 1 ARC-520 Cohort 2 ARC-520 Cohort 3 ARC-520 Cohort 4 ARC-520 Cohort 5
Hide Arm/Group Description:
a single IV dose of double-blind ARC-520 Injection 1.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
a single IV dose of double-blind ARC-520 Injection 2.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
a single IV dose of double-blind ARC-520 Injection 3.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-positive immune active chronic HBV infection
Overall Number of Participants Analyzed 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: 1/hr
AD0009 0.157  (0.0115) 0.132  (0.0242) 0.154  (0.0135) 0.165  (0.0120) 0.161  (0.00614)
AD0010 0.132  (0.0131) 0.111  (0.0188) 0.130  (0.0180) 0.142  (0.0164) 0.126  (0.00793)
13.Secondary Outcome
Title Pharmacokinetics of ARC-520 Product Constituents AD0009 and AD0010: Terminal Elimination Half-Life (t1/2), Cohorts 1-5
Hide Description [Not Specified]
Time Frame Day 1 predose, immediately prior to the end of infusion, 0.5, 1, 3, 6, 24, and 48 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: all participants who received at least 1 dose of study drug and had evaluable PK data.
Arm/Group Title ARC-520 Cohort 1 ARC-520 Cohort 2 ARC-520 Cohort 3 ARC-520 Cohort 4 ARC-520 Cohort 5
Hide Arm/Group Description:
a single IV dose of double-blind ARC-520 Injection 1.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
a single IV dose of double-blind ARC-520 Injection 2.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
a single IV dose of double-blind ARC-520 Injection 3.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection
a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-positive immune active chronic HBV infection
Overall Number of Participants Analyzed 6 6 6 6 6
Median (Full Range)
Unit of Measure: hours
AD0009 Number Analyzed 6 participants 5 participants 6 participants 6 participants 6 participants
4.38
(4.06 to 4.96)
5.36
(4.16 to 7.00)
4.64
(3.87 to 4.90)
4.18
(3.92 to 4.87)
4.32
(4.14 to 4.60)
AD0010 Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants
5.29
(4.76 to 6.19)
6.32
(5.09 to 7.94)
5.48
(4.26 to 6.41)
4.79
(4.32 to 6.15)
5.36
(5.16 to 6.02)
Time Frame From first dose of study drug through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ARC-520 Cohort 1 ARC-520 Cohort 2 ARC-520 Cohort 3 ARC-520 Cohort 4 ARC-520 Cohort 5 ARC-520 Cohort 6 ARC-520 Cohort 7 ARC-520 Cohort 9 ARC-520 Cohort 10 Placebo Normal Saline Cohorts 1-5
Hide Arm/Group Description a single IV dose of double-blind ARC-520 Injection 1.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection a single IV dose of double-blind ARC-520 Injection 2.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection a single IV dose of double-blind ARC-520 Injection 3.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-negative immune active chronic HBV infection a single IV dose of double-blind ARC-520 Injection 4.0 mg/kg in combination with entecavir administered to participants with HBeAg-positive immune active chronic HBV infection two IV doses of open-label ARC-520 2.0 mg/kg administered to participants with HBeAg-positive immune-active chronic HBV a single IV dose of open-label ARC-520 4.0 mg/kg administered to treatment-naïve, HBeAg-negative or -positive participants with CHB open-label multi-dose extension cohort: multiple IV doses of open-label ARC-520 (4.0 mg/kg Q6 weeks or Q8 weeks) administered to HBeAg-positive participants with CHB receiving chronic entecavir therapy who completed Cohorts 5 or 6 open-label multi-dose extension cohort: multiple IV doses of open-label ARC-520 (4.0 mg/kg Q4 weeks) administered to a mixed cohort (HBeAg-negative and -positive participants) who were naïve (within the last 6 months) to entecavir treatment and completed Cohort 7 a single IV dose of double-blind normal saline in combination with entecavir administered to participants with HBeAg-negative or -positive immune active chronic HBV infection
All-Cause Mortality
ARC-520 Cohort 1 ARC-520 Cohort 2 ARC-520 Cohort 3 ARC-520 Cohort 4 ARC-520 Cohort 5 ARC-520 Cohort 6 ARC-520 Cohort 7 ARC-520 Cohort 9 ARC-520 Cohort 10 Placebo Normal Saline Cohorts 1-5
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
ARC-520 Cohort 1 ARC-520 Cohort 2 ARC-520 Cohort 3 ARC-520 Cohort 4 ARC-520 Cohort 5 ARC-520 Cohort 6 ARC-520 Cohort 7 ARC-520 Cohort 9 ARC-520 Cohort 10 Placebo Normal Saline Cohorts 1-5
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/12 (0.00%)   0/2 (0.00%)   0/8 (0.00%)   0/10 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
ARC-520 Cohort 1 ARC-520 Cohort 2 ARC-520 Cohort 3 ARC-520 Cohort 4 ARC-520 Cohort 5 ARC-520 Cohort 6 ARC-520 Cohort 7 ARC-520 Cohort 9 ARC-520 Cohort 10 Placebo Normal Saline Cohorts 1-5
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/6 (16.67%)   4/6 (66.67%)   1/6 (16.67%)   0/6 (0.00%)   1/6 (16.67%)   1/6 (16.67%)   1/12 (8.33%)   1/2 (50.00%)   7/8 (87.50%)   0/10 (0.00%) 
Gastrointestinal disorders                     
Diarrhoea  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  1/2 (50.00%)  0/8 (0.00%)  0/10 (0.00%) 
Epigastric discomfort  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  0/2 (0.00%)  1/8 (12.50%)  0/10 (0.00%) 
General disorders                     
Pyrexia  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/12 (0.00%)  0/2 (0.00%)  5/8 (62.50%)  0/10 (0.00%) 
Influenza like illness  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  0/2 (0.00%)  5/8 (62.50%)  0/10 (0.00%) 
Malaise  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  0/2 (0.00%)  1/8 (12.50%)  0/10 (0.00%) 
Chest discomfort  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  0/2 (0.00%)  1/8 (12.50%)  0/10 (0.00%) 
Infusion site extravasation  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/10 (0.00%) 
Infections and infestations                     
Influenza  1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/12 (8.33%)  0/2 (0.00%)  1/8 (12.50%)  0/10 (0.00%) 
Injury, poisoning and procedural complications                     
Procedural pain  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  0/2 (0.00%)  1/8 (12.50%)  0/10 (0.00%) 
Investigations                     
Blood creatine phosphokinase increased  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/10 (0.00%) 
Metabolism and nutrition disorders                     
Diabetes mellitus  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/10 (0.00%) 
Musculoskeletal and connective tissue disorders                     
Arthralgia  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  0/2 (0.00%)  1/8 (12.50%)  0/10 (0.00%) 
Pain in extremity  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/10 (0.00%) 
Temporomandibular joint syndrome  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  0/2 (0.00%)  1/8 (12.50%)  0/10 (0.00%) 
Nervous system disorders                     
Headache  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/12 (0.00%)  0/2 (0.00%)  1/8 (12.50%)  0/10 (0.00%) 
Dizziness  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/12 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/10 (0.00%) 
Presyncope  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  0/2 (0.00%)  0/8 (0.00%)  0/10 (0.00%) 
Renal and urinary disorders                     
Haematuria  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  0/2 (0.00%)  1/8 (12.50%)  0/10 (0.00%) 
Respiratory, thoracic and mediastinal disorders                     
Rhinorrhoea  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  0/2 (0.00%)  1/8 (12.50%)  0/10 (0.00%) 
Skin and subcutaneous tissue disorders                     
Rash  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  0/2 (0.00%)  2/8 (25.00%)  0/10 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
The ARC-520 Injection development program was terminated early for regulatory and business reasons secondary to findings occurring in a non-clinical toxicology study. Program termination was not due to safety findings in humans.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
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Name/Title: Chief Operating Officer
Organization: Arrowhead Pharmaceuticals, Inc.
Phone: 626-304-3400
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Responsible Party: Arrowhead Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02065336    
Other Study ID Numbers: Heparc-2001
First Submitted: February 13, 2014
First Posted: February 19, 2014
Results First Submitted: January 10, 2018
Results First Posted: July 5, 2019
Last Update Posted: July 5, 2019