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Trial record 1 of 1 for:    NCT01441180
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GS-7977 With Ribavirin for Hepatitis C (SPARE)

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ClinicalTrials.gov Identifier: NCT01441180
Recruitment Status : Completed
First Posted : September 27, 2011
Results First Posted : September 26, 2014
Last Update Posted : September 26, 2014
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C
Interventions Drug: GS7977
Drug: RBV
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Phase 1 Phase 2 Arm A Phase 2 Arm B
Hide Arm/Group Description (N =10): Participants will be enrolled and will receive GS-7977 QD in combination with RBV for a total of 24 weeks. The study team will perform an interim evaluation of data and safety at the end of 12 weeks of treatment. (N =25): 24 weeks of GS-7977 QD in combination with weight based RBV (1000 mg for participants weighing <75 kg and 1200 mg for participants weighing ≥75kg) (N = 25): 24 weeks of GS-7977 QD with low dose RBV (600mg).
Period Title: Overall Study
Started 10 25 25
Completed 9 24 22
Not Completed 1 1 3
Reason Not Completed
Lost to Follow-up             1             1             1
Discontinued             0             0             2
Arm/Group Title Phase 1 Phase 2 Arm A Phase 2 Arm B Total
Hide Arm/Group Description (N =10): Participants will be enrolled and will receive GS-7977 QD in combination with RBV for a total of 24 weeks. The study team will perform an interim evaluation of data and safety at the end of 12 weeks of treatment. (N =25): 24 weeks of GS-7977 QD in combination with weight based RBV (1000 mg for participants weighing <75 kg and 1200 mg for participants weighing ≥75kg) (N = 25): 24 weeks of GS-7977 QD with low dose RBV (600mg). Total of all reporting groups
Overall Number of Baseline Participants 10 25 25 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 25 participants 25 participants 60 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
25
 100.0%
25
 100.0%
60
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 25 participants 25 participants 60 participants
Female
6
  60.0%
6
  24.0%
11
  44.0%
23
  38.3%
Male
4
  40.0%
19
  76.0%
14
  56.0%
37
  61.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 25 participants 25 participants 60 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
9
  90.0%
18
  72.0%
23
  92.0%
50
  83.3%
White
1
  10.0%
6
  24.0%
2
   8.0%
9
  15.0%
More than one race
0
   0.0%
1
   4.0%
0
   0.0%
1
   1.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 25 participants 25 participants 60 participants
Hispanic or Latino
0
   0.0%
2
   8.0%
0
   0.0%
2
   3.3%
Not Hispanic or Latino
10
 100.0%
23
  92.0%
25
 100.0%
58
  96.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 25 participants 25 participants 60 participants
10 25 25 60
1.Primary Outcome
Title Participants With Adverse Events
Hide Description Number of participants with Grade 3-4 Adverse Events During the Study Treatment Period as a measure of safety and tolerability.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase 1 Phase 2 Arm A (Sofosbuvir + Weight Based RBV) Phase 2 Arm B (Sofosbuvir + Low-dose RBV)
Hide Arm/Group Description:
[Not Specified]
(N =25): 24 weeks of GS-7977 QD in combination with weight based RBV (1000 mg for participants weighing <75 kg and 1200 mg for participants weighing ≥75kg)
(N = 25): 24 weeks of GS-7977 QD with low dose RBV (600mg).
Overall Number of Participants Analyzed 10 25 25
Measure Type: Number
Unit of Measure: partipants
Any grade 3-4 event 1 1 5
Any Serious Adverse Event 0 0 1
Death 0 0 0
Discontinuation owing to an adverse event 0 0 0
2.Primary Outcome
Title Sustained Virologic Response
Hide Description Sustained virology response at 24 weeks post treatment completion
Time Frame 24 weeks post treatment completion
Hide Outcome Measure Data
Hide Analysis Population Description
on protocol analysis
Arm/Group Title Phase 1 Phase 2 Arm A Phase 2 Arm B
Hide Arm/Group Description:

Participants (N =10) will receive GS-7977 QD in combination with RBV for a total of 24 weeks. The study team will perform an interim evaluation of data and safety at the end of 12 weeks of treatment.

GS7977

RBV

(N =25) 24 weeks of GS-7977 QD in combination with weight based RBV (1000 mg for participants weighing <75 kg and 1200 mg for participants weighing ≥75kg)

GS7977

RBV

(N = 25): 24 weeks of GS-7977 QD with low dose RBV (600mg).

GS7977

RBV

Overall Number of Participants Analyzed 10 25 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of total participants
100
(66 to 100)
71
(49 to 87)
55
(32 to 76)
Time Frame Entire treatment period through 12 weeks post treatment completion
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Phase 1 (Sofosbuvir + Weight Based RBV) Phase 2 Arm A (Sofosbuvir + Weight Based RBV) Phase 2 Arm B (Sofosbuvir + Low-dose RBV)
Hide Arm/Group Description (N =10): 24 weeks of GS-7977 QD in combination with weight based RBV (1000 mg for participants weighing <75 kg and 1200 mg for participants weighing ≥75kg) (N =25): 24 weeks of GS-7977 QD in combination with weight based RBV (1000 mg for participants weighing <75 kg and 1200 mg for participants weighing ≥75kg) (N = 25): 24 weeks of GS-7977 QD with low dose RBV (600mg).
All-Cause Mortality
Phase 1 (Sofosbuvir + Weight Based RBV) Phase 2 Arm A (Sofosbuvir + Weight Based RBV) Phase 2 Arm B (Sofosbuvir + Low-dose RBV)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Phase 1 (Sofosbuvir + Weight Based RBV) Phase 2 Arm A (Sofosbuvir + Weight Based RBV) Phase 2 Arm B (Sofosbuvir + Low-dose RBV)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/25 (0.00%)      2/25 (8.00%)    
Gastrointestinal disorders       
Pancreatitis * 1  0/10 (0.00%)  0 0/25 (0.00%)  0 1/25 (4.00%)  1
Hepatobiliary disorders       
Cholelithiasis * 1  0/10 (0.00%)  0 0/25 (0.00%)  0 1/25 (4.00%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Phase 1 (Sofosbuvir + Weight Based RBV) Phase 2 Arm A (Sofosbuvir + Weight Based RBV) Phase 2 Arm B (Sofosbuvir + Low-dose RBV)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/10 (90.00%)      24/25 (96.00%)      21/25 (84.00%)    
Gastrointestinal disorders       
Nausea * 1  1/10 (10.00%)  1 4/25 (16.00%)  4 5/25 (20.00%)  7
Vomiting * 1  0/10 (0.00%)  0 0/25 (0.00%)  0 3/25 (12.00%)  3
Abdominal Pain * 1  1/10 (10.00%)  1 0/25 (0.00%)  0 0/25 (0.00%)  0
Lip swelling * 1  1/10 (10.00%)  2 0/25 (0.00%)  0 0/25 (0.00%)  0
General disorders       
Fatigue * 1  3/10 (30.00%)  4 4/25 (16.00%)  5 6/25 (24.00%)  6
Hepatobiliary disorders       
Hyperbiliurbinemia * 1  2/10 (20.00%)  5 8/25 (32.00%)  24 3/25 (12.00%)  6
Investigations       
Blood glucose increased * 1  0/10 (0.00%)  0 1/25 (4.00%)  2 2/25 (8.00%)  2
Creatinine increased * 1  0/10 (0.00%)  0 2/25 (8.00%)  3 3/25 (12.00%)  7
Hemoglobin decreased * 1  4/10 (40.00%)  7 8/25 (32.00%)  16 4/25 (16.00%)  9
Serum calcium decreased * 1  1/10 (10.00%)  1 6/25 (24.00%)  6 5/25 (20.00%)  7
Serum phosphate decreased * 1  0/10 (0.00%)  0 6/25 (24.00%)  9 8/25 (32.00%)  12
Blood phosphorus decreased * 1  2/10 (20.00%)  7 0/25 (0.00%)  0 0/25 (0.00%)  0
Blood magnesium decreased * 1  2/10 (20.00%)  4 0/25 (0.00%)  0 0/25 (0.00%)  0
Blood sodium decreased * 1  2/10 (20.00%)  2 0/25 (0.00%)  0 0/25 (0.00%)  0
Metabolism and nutrition disorders       
Decreased appetite * 1  1/10 (10.00%)  1 0/25 (0.00%)  0 0/25 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Myalgia * 1  0/10 (0.00%)  0 0/25 (0.00%)  0 2/25 (8.00%)  2
Nervous system disorders       
Dizziness * 1  0/10 (0.00%)  0 2/25 (8.00%)  2 1/25 (4.00%)  1
Headache * 1  2/10 (20.00%)  3 7/25 (28.00%)  10 7/25 (28.00%)  8
Light headedness * 1  0/10 (0.00%)  0 1/25 (4.00%)  1 2/25 (8.00%)  2
Respiratory, thoracic and mediastinal disorders       
Dyspnea * 1  1/10 (10.00%)  1 2/25 (8.00%)  2 2/25 (8.00%)  2
Skin and subcutaneous tissue disorders       
Pruritic rash * 1  1/10 (10.00%)  1 3/25 (12.00%)  3 0/25 (0.00%)  0
Rash * 1  1/10 (10.00%)  1 0/25 (0.00%)  0 0/25 (0.00%)  0
Skin Ulcer * 1  1/10 (10.00%)  1 0/25 (0.00%)  0 0/25 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Shyam Kottilil
Organization: NIAID/NIH
Phone: 301-435-0936
EMail: skottilil@niaid.nih.gov
Layout table for additonal information
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier: NCT01441180    
Other Study ID Numbers: 110258
11-I-0258 ( Registry Identifier: CLINICAL TRIALS )
First Submitted: September 24, 2011
First Posted: September 27, 2011
Results First Submitted: April 23, 2014
Results First Posted: September 26, 2014
Last Update Posted: September 26, 2014