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Trial record 47 of 82 for:    GRAZOPREVIR ANHYDROUS AND ELBASVIR

Study of Efficacy and Safety of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in Chronic Hepatitis C Participants With Child-Pugh (CP)-B Hepatic Insufficiency (MK-5172-059)

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ClinicalTrials.gov Identifier: NCT02115321
Recruitment Status : Completed
First Posted : April 16, 2014
Results First Posted : March 17, 2016
Last Update Posted : June 26, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Hepatitis C
Interventions Drug: Grazoprevir
Drug: Elbasvir
Drug: MK-5172A
Enrollment 40
Recruitment Details The screening period lasted for 60 days. Recruitment was halted after enrolling participants in the two Part A arms, as the current clinical development plan is focused on a fixed-dose combination (FDC) product containing grazoprevir (GZR) 100 mg and elbasvir (EBR) 50 mg. No participants were enrolled in Parts B or C.
Pre-assignment Details  
Arm/Group Title Part A: CP-B GZR 50 mg + EBR 50 mg Part A: NC GZR 100 mg + EBR 50 mg
Hide Arm/Group Description Child-Pugh score 7 to 9 (CP-B) participants take GZR 50 mg + EBR 50 mg once daily (q.d.) by mouth for 12 weeks. Non-cirrhotic (NC) participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
Period Title: Overall Study
Started 30 10
Completed 29 10
Not Completed 1 0
Reason Not Completed
Death             1             0
Arm/Group Title Part A: CP-B GZR 50 mg + EBR 50 mg Part A: NC GZR 100 mg + ER 50 mg Total
Hide Arm/Group Description CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks. NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 30 10 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 10 participants 40 participants
58.3  (7.0) 60.4  (5.3) 58.8  (6.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 10 participants 40 participants
Female
13
  43.3%
5
  50.0%
18
  45.0%
Male
17
  56.7%
5
  50.0%
22
  55.0%
1.Primary Outcome
Title Percentage of Participants Achieving Sustained Viral Response 12 Weeks After Completing Study Therapy (SVR12)
Hide Description SVR12 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) levels below the lower limit of quantification (LLoQ) 12 weeks after completing study therapy. HCV RNA was measured with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay which has a LLoQ of 15 IU/mL and a limit of detection of 15 IU/mL.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consists of all randomized participants who received at least one dose of study medication.
Arm/Group Title Part A: CP-B GZR 50 mg + EBR 50 mg Part A: NC GZR 100 mg + ER 50 mg
Hide Arm/Group Description:
CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks.
NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
Overall Number of Participants Analyzed 30 10
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
90.0
(73.5 to 97.9)
100.0
(69.2 to 100.0)
2.Primary Outcome
Title Number of Participants Experiencing an Adverse Event (AE) During Treatment and First 14 Follow-up Days
Hide Description An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Time Frame Up to 14 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one dose of study medication.
Arm/Group Title Part A: CP-B GZR 50 mg + EBR 50 mg Part A: NC GZR 100 mg + ER 50 mg
Hide Arm/Group Description:
CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks.
NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
Overall Number of Participants Analyzed 30 10
Measure Type: Number
Unit of Measure: Number of participants
25 8
3.Primary Outcome
Title Number of Participants Discontinuing Study Drug Due to an AE
Hide Description An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The APaT population consisted of all randomized participants who received at least one dose of study medication.
Arm/Group Title Part A: CP-B GZR 50 mg + EBR 50 mg Part A: NC GZR 100 mg + ER 50 mg
Hide Arm/Group Description:
CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks.
NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
Overall Number of Participants Analyzed 30 10
Measure Type: Number
Unit of Measure: Number of participants
0 0
4.Secondary Outcome
Title Mean Change From Baseline in Model for End-Stage Liver Disease (MELD) Scores in CP-B Participants
Hide Description The MELD score provides an objective and granular assessment of liver improvement as a continuous variable. The calculation of MELD score is based on three biochemical variables (serum bilirubin, creatinine and international normalized ratio [INR] of prothrombin time). The MELD equation is as follows: 9.57 x ln(creatinine mg/dL) +3.78 x ln(bilirubin mg/dL) +11.2 x ln (INR) + 6.43. Scores are multiplied by 10 and rounded to the nearest whole number and range from 6 (less ill) to 40 (gravely ill). MELD scores were determined at Baseline (Day 1) and again at Week 12, Follow-up (FU) Week 12 (Week 24), and FU Week 24 (Week 36). Change from baseline in MELD score = Post-baseline MELD score - baseline MELD score.
Time Frame Baseline and Weeks 12, 24, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
All CP-B participants in the FAS (all randomized participants who received at least one dose of study medication) with available data.
Arm/Group Title Part A: CP-B GZR 50 mg + EBR 50 mg Part A: NC GZR 100 mg + ER 50 mg
Hide Arm/Group Description:
CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks.
NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
Overall Number of Participants Analyzed 30 0
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 12 (n=30) -0.67  (1.35)
FU Week 12 (Week 24) [n=29] -0.38  (1.74)
FU Week 24 (Week 36) [n=29] -0.34  (3.15)
5.Secondary Outcome
Title Percentage of Participants With HCV RNA Undetectable at Weeks 2, 4, and 12
Hide Description HCV RNA was measured with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay which has a LLoQ of 15 IU/mL and a limit of detection of 15 IU/mL.
Time Frame Week 2, 4, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol, this measure was to be determined in Arm 4 (Part C); however, enrollment was halted after Part A and thus no data are available.
Arm/Group Title Part A: CP-B GZR 50 mg + EBR 50 mg Part A: NC GZR 100 mg + ER 50 mg
Hide Arm/Group Description:
CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks.
NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Percentage of Participants With HCV RNA <LLoQ at Weeks 2, 4, and 12
Hide Description HCV RNA was measured with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay which has a LLoQ of 15 IU/mL and a limit of detection of 15 IU/mL.
Time Frame Weeks 2, 4, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol, this measure was to be determined in Arm 4 (Part C); however, enrollment was halted after Part A and thus no data are available.
Arm/Group Title Part A: CP-B GZR 50 mg + EBR 50 mg Part A: NC GZR 100 mg + ER 50 mg
Hide Arm/Group Description:
CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks.
NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Percentage of Participants Achieving Sustained Viral Response 4 Weeks After Completing Study Therapy (SVR4)
Hide Description SVR4 was defined as HCV RNA levels <LLoQ 4 weeks after completing study therapy. HCV RNA was measured with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay which has a LLoQ of 15 IU/mL and a limit of detection of 15 IU/mL.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS consists of all randomized participants who received at least one dose of study medication.
Arm/Group Title Part A: CP-B GZR 50 mg + EBR 50 mg Part A: NC GZR 100 mg + ER 50 mg
Hide Arm/Group Description:
CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks.
NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
Overall Number of Participants Analyzed 30 10
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
93.3
(77.9 to 99.2)
100.0
(69.2 to 100.0)
8.Secondary Outcome
Title Percentage of Participants Achieving Sustained Viral Response 24 Weeks After Completing Study Therapy (SVR24)
Hide Description SVR24 was defined as HCV RNA levels <LLoQ 24 weeks after completing study therapy. HCV RNA was measured with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay which has a LLoQ of 15 IU/mL and a limit of detection of 15 IU/mL.
Time Frame Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS consists of all randomized participants who received at least one dose of study medication.
Arm/Group Title Part A: CP-B GZR 50 mg + EBR 50 mg Part A: NC GZR 100 mg + ER 50 mg
Hide Arm/Group Description:
CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks.
NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
Overall Number of Participants Analyzed 30 10
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
90.0
(73.5 to 97.9)
100.0
(69.2 to 100.0)
Time Frame Up to 36 weeks.
Adverse Event Reporting Description An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
 
Arm/Group Title CP-B: GZR 50 mg + EBR 50 mg for 12 Weeks Non-cirrhotic: GZR 100 mg + EBR 50 mg for 12 Weeks
Hide Arm/Group Description CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks. NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
All-Cause Mortality
CP-B: GZR 50 mg + EBR 50 mg for 12 Weeks Non-cirrhotic: GZR 100 mg + EBR 50 mg for 12 Weeks
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
CP-B: GZR 50 mg + EBR 50 mg for 12 Weeks Non-cirrhotic: GZR 100 mg + EBR 50 mg for 12 Weeks
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/30 (16.67%)      0/10 (0.00%)    
Blood and lymphatic system disorders     
Anaemia  1  1/30 (3.33%)  1 0/10 (0.00%)  0
Gastrointestinal disorders     
Ascites  1  1/30 (3.33%)  1 0/10 (0.00%)  0
Varices oesophageal  1  1/30 (3.33%)  1 0/10 (0.00%)  0
Hepatobiliary disorders     
Hepatic failure  1  1/30 (3.33%)  1 0/10 (0.00%)  0
Infections and infestations     
Peritonitis bacterial  1  1/30 (3.33%)  2 0/10 (0.00%)  0
Metabolism and nutrition disorders     
Malnutrition  1  1/30 (3.33%)  1 0/10 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Hepatocellular carcinoma  1  1/30 (3.33%)  1 0/10 (0.00%)  0
Nervous system disorders     
Cerebral infarction  1  1/30 (3.33%)  1 0/10 (0.00%)  0
Encephalopathy  1  1/30 (3.33%)  1 0/10 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CP-B: GZR 50 mg + EBR 50 mg for 12 Weeks Non-cirrhotic: GZR 100 mg + EBR 50 mg for 12 Weeks
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/30 (66.67%)      8/10 (80.00%)    
Blood and lymphatic system disorders     
Increased tendency to bruise  1  0/30 (0.00%)  0 1/10 (10.00%)  1
Ear and labyrinth disorders     
Ear discomfort  1  0/30 (0.00%)  0 1/10 (10.00%)  1
Eye disorders     
Retinal detachment  1  0/30 (0.00%)  0 1/10 (10.00%)  1
Gastrointestinal disorders     
Abdominal discomfort  1  1/30 (3.33%)  1 1/10 (10.00%)  1
Abdominal pain  1  2/30 (6.67%)  2 1/10 (10.00%)  1
Abdominal pain upper  1  0/30 (0.00%)  0 1/10 (10.00%)  1
Diarrhoea  1  2/30 (6.67%)  2 0/10 (0.00%)  0
Nausea  1  3/30 (10.00%)  3 2/10 (20.00%)  2
Vomiting  1  2/30 (6.67%)  2 0/10 (0.00%)  0
Constipation  1  0/30 (0.00%)  0 1/10 (10.00%)  1
General disorders     
Chills  1  2/30 (6.67%)  2 0/10 (0.00%)  0
Fatigue  1  9/30 (30.00%)  11 3/10 (30.00%)  3
Feeling abnormal  1  0/30 (0.00%)  0 1/10 (10.00%)  1
Pyrexia  1  3/30 (10.00%)  3 0/10 (0.00%)  0
Infections and infestations     
Influenza  1  3/30 (10.00%)  3 0/10 (0.00%)  0
Tooth infection  1  0/30 (0.00%)  0 1/10 (10.00%)  1
Urinary tract infection  1  3/30 (10.00%)  3 0/10 (0.00%)  0
Pneumonia  1  0/30 (0.00%)  0 1/10 (10.00%)  1
Injury, poisoning and procedural complications     
Ligament sprain  1  0/30 (0.00%)  0 1/10 (10.00%)  1
Muscle strain  1  0/30 (0.00%)  0 1/10 (10.00%)  1
Investigations     
Blood creatine phosphokinase increased  1  0/30 (0.00%)  0 1/10 (10.00%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  5/30 (16.67%)  5 2/10 (20.00%)  3
Myalgia  1  2/30 (6.67%)  2 0/10 (0.00%)  0
Nervous system disorders     
Dizziness  1  2/30 (6.67%)  2 0/10 (0.00%)  0
Headache  1  3/30 (10.00%)  3 5/10 (50.00%)  6
Sinus headache  1  0/30 (0.00%)  0 1/10 (10.00%)  1
Psychiatric disorders     
Affect lability  1  0/30 (0.00%)  0 1/10 (10.00%)  1
Insomnia  1  2/30 (6.67%)  2 1/10 (10.00%)  1
Respiratory, thoracic and mediastinal disorders     
Cough  1  2/30 (6.67%)  2 1/10 (10.00%)  1
Oropharyngeal pain  1  0/30 (0.00%)  0 1/10 (10.00%)  1
Sinus congestion  1  0/30 (0.00%)  0 1/10 (10.00%)  1
Skin and subcutaneous tissue disorders     
Acne  1  0/30 (0.00%)  0 1/10 (10.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02115321     History of Changes
Other Study ID Numbers: 5172-059
2014-000672-25 ( EudraCT Number )
First Submitted: April 14, 2014
First Posted: April 16, 2014
Results First Submitted: February 19, 2016
Results First Posted: March 17, 2016
Last Update Posted: June 26, 2019