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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-28

Study Completion Date

2012-05-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatitis C, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Grazoprevir 200 mg + Peg-IFN + RBV

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

Group Type EXPERIMENTAL

Grazoprevir

Intervention Type DRUG

Grazoprevir 100 mg tablets once daily for 12 weeks.

Peginterferon alfa-2b (Peg-IFN)

Intervention Type DRUG

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

Ribavirin (RBV)

Intervention Type DRUG

Ribavirin 200 mg capsules twice daily at a dose of 600 mg to 1400 mg based on weight for 12 or 24 weeks

Grazoprevir 400 mg + Peg-IFN + RBV

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

Group Type EXPERIMENTAL

Grazoprevir

Intervention Type DRUG

Grazoprevir 100 mg tablets once daily for 12 weeks.

Peginterferon alfa-2b (Peg-IFN)

Intervention Type DRUG

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

Ribavirin (RBV)

Intervention Type DRUG

Ribavirin 200 mg capsules twice daily at a dose of 600 mg to 1400 mg based on weight for 12 or 24 weeks

Placebo + Peg-IFN + 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.

Group Type PLACEBO_COMPARATOR

Placebo to Grazoprevir

Intervention Type DRUG

Placebo to Grazoprevir once daily for 12 weeks

Peginterferon alfa-2b (Peg-IFN)

Intervention Type DRUG

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

Ribavirin (RBV)

Intervention Type DRUG

Ribavirin 200 mg capsules twice daily at a dose of 600 mg to 1400 mg based on weight for 12 or 24 weeks

Grazoprevir 800 mg + Peg-IFN + RBV

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

Group Type EXPERIMENTAL

Grazoprevir

Intervention Type DRUG

Grazoprevir 100 mg tablets once daily for 12 weeks.

Peginterferon alfa-2b (Peg-IFN)

Intervention Type DRUG

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

Ribavirin (RBV)

Intervention Type DRUG

Ribavirin 200 mg capsules twice daily at a dose of 600 mg to 1400 mg based on weight for 12 or 24 weeks

Interventions

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Grazoprevir

Grazoprevir 100 mg tablets once daily for 12 weeks.

Intervention Type DRUG

Placebo to Grazoprevir

Placebo to Grazoprevir once daily for 12 weeks

Intervention Type DRUG

Peginterferon alfa-2b (Peg-IFN)

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

Intervention Type DRUG

Ribavirin (RBV)

Ribavirin 200 mg capsules twice daily at a dose of 600 mg to 1400 mg based on weight for 12 or 24 weeks

Intervention Type DRUG

Other Intervention Names

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MK-5172 PegIntron®, SCH 054031 Rebetol®, SCH 018908

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No