Grazoprevir (MK-5172) With Peg-Interferon and Ribavirin in Participants With Chronic Genotype 2 or 3 Hepatitis C (MK-5172-012)
- Conditions
- Hepatitis C, Chronic
- Interventions
- Drug: Peginterferon alfa-2b (Peg-IFN)
- Registration Number
- NCT01440595
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 5
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Grazoprevir 200 mg + Peg-IFN + RBV Grazoprevir Grazoprevir 200 mg in combination with Peg-IFN and RBV for 12 weeks. Grazoprevir 200 mg + Peg-IFN + RBV Peginterferon alfa-2b (Peg-IFN) Grazoprevir 200 mg in combination with Peg-IFN and RBV for 12 weeks. Grazoprevir 200 mg + Peg-IFN + RBV Ribavirin (RBV) Grazoprevir 200 mg in combination with Peg-IFN and RBV for 12 weeks. Grazoprevir 400 mg + Peg-IFN + RBV Peginterferon alfa-2b (Peg-IFN) Grazoprevir 400 mg in combination with Peg-IFN and RBV for 12 weeks. Grazoprevir 400 mg + Peg-IFN + RBV Ribavirin (RBV) Grazoprevir 400 mg in combination with Peg-IFN and RBV for 12 weeks. Placebo + Peg-IFN + RBV Placebo to Grazoprevir Placebo 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. Placebo + Peg-IFN + RBV Peginterferon alfa-2b (Peg-IFN) Placebo 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. Placebo + Peg-IFN + RBV Ribavirin (RBV) Placebo 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 Grazoprevir Grazoprevir 800 mg in combination with Peg-IFN and RBV for 12 weeks. Grazoprevir 800 mg + Peg-IFN + RBV Peginterferon alfa-2b (Peg-IFN) Grazoprevir 800 mg in combination with Peg-IFN and RBV for 12 weeks. Grazoprevir 800 mg + Peg-IFN + RBV Ribavirin (RBV) Grazoprevir 800 mg in combination with Peg-IFN and RBV for 12 weeks. Grazoprevir 400 mg + Peg-IFN + RBV Grazoprevir Grazoprevir 400 mg in combination with Peg-IFN and RBV for 12 weeks.
- Primary Outcome Measures
Name Time Method Number of Participants Achieving Complete Early Virologic Response (cEVR) in the Grazoprevir Treatment Arms Week 12 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.
- Secondary Outcome Measures
Name Time Method Number of Participants Achieving Rapid Viral Response (RVR) Week 4 RVR was defined as undetectable HCV RNA at Week 4. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.
Time to First Achievement of Undetectable HCV Ribonucleic Acid (RNA) Baseline to Week 12 for Grazoprevir treatment arms, Week 24 for Placebo arm Time to first achievement of undetectable HCV RNA was determined by measuring HCV RNA at Treatment Days 1, 3, and 7; Treatment Weeks 2, 4, 8, 12, 16, 20, and 24; as well as Follow-up Weeks 4, 12, and 24. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.
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 SVR24 was defined as undetectable HCV RNA 24 weeks after completion of study therapy. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.
Number of Participants Achieving Undetectable HCV RNA at Week 12 in the Placebo Arm Week 12 HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.
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 SVR12 was defined as undetectable HCV RNA 12 weeks after completion of study therapy. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.
Number of Participants Achieving Complete Early Virologic Response (cEVR) at Week 24 in the Placebo Arm Week 24 cEVR was defined as undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 24 (i.e., after 12 weeks of placebo + 12 weeks of grazoprevir treatment). HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.