Status:
COMPLETED
The Effect of Boceprevir in Russian Participants Diagnosed With Chronic Hepatitis C Genotype 1 (P08160)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Chronic Hepatitis C Genotype 1
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 treatme...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 23 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 21 2013
Estimated Enrollment :
238 Patients enrolled
Trial Details
Trial ID
NCT01425203
Start Date
November 23 2011
End Date
October 21 2013
Last Update
February 8 2021
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