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Completed

NCT Number: NCT01425203

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

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.

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Key information

Conditions

Chronic Hepatitis C Genotype 1

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

boceprevir

Drug

boceprevir 200-mg capsules, 800 mg 3 times a day (TID), orally (PO)

Other names: SCH 503034

Placebo

Drug

boceprevir-matched placebo four 200-mg capsules PO TID.

Peginterferon alfa-2b

Biological

peginterferon alfa-2b 1.5 μg/kg/wk subcutaneously (SC)

Other names: PegIntron

Ribavirin

Drug

ribavirin (weight-based dosing) 800 to 1400 mg/day PO divided twice daily dose (BID).

Primary outcomes

  1. 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)

    Time frame: Follow-up Week 24 (up to 72 weeks)

    SVR24 was defined as an undetectable plasma Hepatitis C Virus-ribonucleic acid (HCV-RNA) level at Follow-up Week 24 (FW24). If a participant was missing FW24 data and had undetectable HCV-RNA at FW12, the participant was considered a sustained virologic responder.

Secondary outcomes

  1. Percentage of Participants Achieving SVR24 Among Participants Who Received At Least One Dose of Experimental Trial Drug (Modified Intent-To-Treat [mITT] Population)

    Time frame: Follow-up Week 24 (up to 72 weeks)

    SVR24 was defined as an undetectable plasma HCV-RNA level at FW24. If a participant was missing FW24 data and had undetectable HCV-RNA at FW12, the participant was considered a sustained virologic responder.

  2. Percentage of Participants Achieving Early Virologic Response (EVR) At Treatment Week (TW) 8

    Time frame: Treatment Week 8

    EVR was defined as an undetectable HCV-RNA level at TW 8. This analysis was conducted when all participants had completed 8 weeks of the study or had discontinued prior to TW 8.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 29, 2011
Registry last updated
Feb 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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