Grazoprevir (MK-5172) With Peg-Interferon and Ribavirin in Participants With Chronic Genotype 2 or 3 Hepatitis C (MK-5172-012)

Phase 2TerminatedNCT01440595

Merck Sharp & Dohme LLC5 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hepatitis C, Chronic

Interventions

GrazoprevirDRUG

Grazoprevir 100 mg tablets once daily for 12 weeks.

Placebo to GrazoprevirDRUG

Placebo to Grazoprevir once daily for 12 weeks

Peginterferon alfa-2b (Peg-IFN)DRUG

Peg-IFN weekly subcutaneous injection at 1.5 mcg/kg/week for 12 or 24 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Outcomes

Primary Outcomes

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.

Time frame: Week 12

Secondary Outcomes

Time to First Achievement of Undetectable HCV Ribonucleic Acid (RNA)

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.

Time frame: Baseline to Week 12 for Grazoprevir treatment arms, Week 24 for Placebo arm

Number of Participants Achieving Rapid Viral Response (RVR)

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 frame: Week 4

Number of Participants Achieving Sustained Viral Response 12 Weeks After Completion of Therapy (SVR12)

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.

Time frame: 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)

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.

Time frame: 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

Data from ClinicalTrials.gov

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