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

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 2

Conditions: Hepatitis C, Chronic

Treatments: Drug: Grazoprevir; Drug: Peginterferon alfa-2b (Peg-IFN); Drug: Ribavirin (RBV); Drug: Placebo to Grazoprevir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01440595

5172-012

2011-003299-36 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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5 participants in 4 patient groups, including a placebo group

Grazoprevir 200 mg + Peg-IFN + RBV

Experimental group

Description:

Grazoprevir 200 mg in combination with Peg-IFN and RBV for 12 weeks.

Treatment:

Drug: Ribavirin (RBV)

Drug: Peginterferon alfa-2b (Peg-IFN)

Drug: Grazoprevir

Grazoprevir 400 mg + Peg-IFN + RBV

Experimental group

Description:

Grazoprevir 400 mg in combination with Peg-IFN and RBV for 12 weeks.

Treatment:

Drug: Ribavirin (RBV)

Drug: Peginterferon alfa-2b (Peg-IFN)

Drug: Grazoprevir

Placebo + Peg-IFN + RBV

Placebo Comparator group

Description:

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.

Treatment:

Drug: Ribavirin (RBV)

Drug: Peginterferon alfa-2b (Peg-IFN)

Drug: Placebo to Grazoprevir

Grazoprevir 800 mg + Peg-IFN + RBV

Experimental group

Description:

Grazoprevir 800 mg in combination with Peg-IFN and RBV for 12 weeks.

Treatment:

Drug: Ribavirin (RBV)

Drug: Peginterferon alfa-2b (Peg-IFN)

Drug: Grazoprevir