Clinical trial NCT01425203: The Effect of Boceprevir in Russian Participants Diagnosed With Chronic Hepatitis C Genotype 1 (P08160)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hepatitis C Genotype 1
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2011-08-29
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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 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

Primary outcomes:
measure: Percentage of Participants Achieving Sustained Virologic Response At Follow-up Week 24 (SVR24) Among Participants Who Received At Least One Dose of Any Trial Medication (Full Analysis Set Population)
timeFrame: Follow-up Week 24 (up to 72 weeks)
Secondary outcomes:
measure: Percentage of Participants Achieving SVR24 Among Participants Who Received At Least One Dose of Experimental Trial Drug (Modified Intent-To-Treat [mITT] Population)
timeFrame: Follow-up Week 24 (up to 72 weeks)
measure: Percentage of Participants Achieving Early Virologic Response (EVR) At Treatment Week (TW) 8
timeFrame: Treatment Week 8
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Isakov V, Nikitin I, Chulanov V, Ogurtsov P, Lukyanova E, Long J, Wahl J, Helmond FA; P08160 Trial Investigators. Boceprevir plus peginterferon/ribavirin for treatment of chronic hepatitis C in Russia. World J Hepatol. 2016 Feb 28;8(6):331-9. doi: 10.4254/wjh.v8.i6.331.