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The Effect of Boceprevir in Russian Participants Diagnosed With Chronic Hepatitis C Genotype 1 (P08160) | Clinical Trials | Clareo Health

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

Safety and Efficacy of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin for Treatment of Chronic Hepatitis C Genotype 1 in Russia: Previously Untreated Patients and Patients Who Failed Prior Treatment With Pegylated-Interferon Plus Ribavirin

NCT01425203•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Key Dates

Start Date

November 23, 2011

Primary Completion Date

October 21, 2013

Completion Date

October 21, 2013

Last Updated

February 8, 2021

Enrollment

238

ACTUAL participants

Conditions

Chronic Hepatitis C Genotype 1

Interventions

Boceprevir

DRUG

Placebo

DRUG

peginterferon alfa-2b

BIOLOGICAL

Ribavirin

DRUG