The Effect of Boceprevir in Russian Participants Diagnosed With Chronic Hepatitis C Genotype 1 (P08160)

• Status: Completed
• Trial end date: 2013-10-21
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether Boceprevir (BOC, SCH 503034, MK-3034) in combination with Peginterferon Alfa 2-b (PEG) plus Ribavirin (RBV) [PEG+RBV=PR] is effective in the treatment of chronic hepatitis C (CHC) genotype 1 among the Russian population. The primary hypothesis is that the percentage of participants achieving sustained virologic response in the BOC + PR group is superior to that in the Placebo (PBO) + PR group.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Interferon-alpha; Peginterferon alfa-2b; Ribavirin

Criteria

Inclusion criteria:

• body weight ≥40 kg and ≤125 kg

• previously documented CHC genotype 1 infection;

• must have a liver biopsy with histology consistent with CHC and no other etiology

• if cirrhosis present, must have an ultrasound within 6 months of the screening visit (or between screening and Day 1) with no findings suspicious for hepatocellular carcinoma (HCC)

• agree to use acceptable methods of contraception with partner

• previously untreated with pegylated-interferon (either alfa-2a or alfa-2b) plus RBV or failing prior treatment with pegylated-interferon (either alfa-2a or alfa-2b) plus RBV

Exclusion criteria:

• co-infected with the human immunodeficiency virus (HIV) or hepatitis B virus (Hepatitis B surface antigen [HBsAg] positive).

• required discontinuation of previous interferon or ribavirin regimen for an adverse event (possibly or probably related)

• treatment with ribavirin within 90 days and any interferon-alpha, based on the amendment, should be within 1 month prior to screening

• treatment with any investigational drug within 30 days of the screening visit in this trial

• evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy

• diabetic and/or hypertensive with clinically significant ocular examination findings

• clinical diagnosis of substance abuse of specified drugs within specified timeframes

• any known pre-existing medical condition that could interfere with the participant's participation in and completion of the trial