Study Stopped
Preliminary results of MK-5172 PN003 (NCT01353911) suggested a possible dose relationship to elevated transaminase levels in treatment with grazoprevir.
Grazoprevir (MK-5172) With Peg-Interferon and Ribavirin in Participants With Chronic Genotype 2 or 3 Hepatitis C (MK-5172-012)
A Randomized, Partially Double-Blind, Active-Controlled, Dose-Ranging Estimation Study to Evaluate the Safety, Tolerability, and Efficacy of Different Regimens of MK-5172 When Administered Concomitantly With Pegylated-Interferon and Ribavirin in Treatment-Naive Patients With Chronic Genotype 2 or 3 Hepatitis C Virus Infection
2 other identifiers
interventional
5
0 countries
N/A
Brief Summary
This study will evaluate the safety, tolerability, and antiviral activity of grazoprevir (MK-5172) when administered concomitantly with peg-interferon alfa-2b (Peg-IFN) and ribavirin (RBV) to treatment-naïve participants with chronic genotype 2 (GT2) or genotype 3 (GT3) hepatitis C virus (HCV) infections.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Nov 2011
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2011
CompletedFirst Posted
Study publicly available on registry
September 26, 2011
CompletedStudy Start
First participant enrolled
November 28, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedResults Posted
Study results publicly available
March 4, 2016
CompletedMay 22, 2024
May 1, 2024
5 months
September 22, 2011
February 3, 2016
May 20, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants Achieving Complete Early Virologic Response (cEVR) in the Grazoprevir Treatment Arms
cEVR was defined as undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v.2.0 assay.
Week 12
Secondary Outcomes (6)
Time to First Achievement of Undetectable HCV Ribonucleic Acid (RNA)
Baseline to Week 12 for Grazoprevir treatment arms, Week 24 for Placebo arm
Number of Participants Achieving Rapid Viral Response (RVR)
Week 4
Number of Participants Achieving Sustained Viral Response 12 Weeks After Completion of Therapy (SVR12)
Week 24 for Grazoprevir treatment arms, Week 36 for Placebo arm
Number of Participants Achieving Sustained Viral Response 24 Weeks After Completion of Therapy (SVR24)
Week 36 for Grazoprevir treatment arms, Week 48 for Placebo arm
Number of Participants Achieving Undetectable HCV RNA at Week 12 in the Placebo Arm
Week 12
- +1 more secondary outcomes
Study Arms (4)
Grazoprevir 200 mg + Peg-IFN + RBV
EXPERIMENTALGrazoprevir 200 mg in combination with Peg-IFN and RBV for 12 weeks.
Grazoprevir 400 mg + Peg-IFN + RBV
EXPERIMENTALGrazoprevir 400 mg in combination with Peg-IFN and RBV for 12 weeks.
Placebo + Peg-IFN + RBV
PLACEBO COMPARATORPlacebo to grazoprevir in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.
Grazoprevir 800 mg + Peg-IFN + RBV
EXPERIMENTALGrazoprevir 800 mg in combination with Peg-IFN and RBV for 12 weeks.
Interventions
Grazoprevir 100 mg tablets once daily for 12 weeks.
Peg-IFN weekly subcutaneous injection at 1.5 mcg/kg/week for 12 or 24 weeks
Ribavirin 200 mg capsules twice daily at a dose of 600 mg to 1400 mg based on weight for 12 or 24 weeks
Eligibility Criteria
You may qualify if:
- Body weight ≥ 88 lbs and ≤ 275 lbs
- Documented chronic Hepatitis C (CHC) GT2 or GT3 infection
- No known cirrhosis
- Agrees to use two acceptable methods of birth control during study and through 6 months after last dose of study drug
- Chest X-ray within the last 6 months
- Eye exam within the last 6 months
You may not qualify if:
- Known to be human immunodeficiency virus (HIV) positive or co-infected with active hepatitis B virus (positive for Hepatitis B surface antigen)
- Prior approved or investigational treatment for hepatitis C
- Evidence of hepatocellular carcinoma
- Diabetic and/or high blood pressure with clinically significant eye exam findings
- Pre-existing psychiatric condition
- Clinical diagnosis of abuse of certain substances within specified timeframes
- Known medical condition that could interfere with participation
- Active or suspected cancer within the last 5 years
- Female who is pregnant, breastfeeding, or expecting to conceive or donate eggs
- Male who is planning to impregnate partner or donate sperm
- Male with a pregnant female partner
- Chronic hepatitis not caused by HCV
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp.
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2011
First Posted
September 26, 2011
Study Start
November 28, 2011
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
May 22, 2024
Results First Posted
March 4, 2016
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will share
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf