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

January 15, 2021 updated by: Merck Sharp & Dohme LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

238

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: RGT BOC + PR
Participants received PR for 4 weeks before addition of BOC. Participants then received response guided therapy (RGT) with BOC + PR for up to 32 weeks followed by PBO + PR for up to 20 weeks.
Drug: Boceprevir
boceprevir 200-mg capsules, 800 mg 3 times a day (TID), orally (PO)
Other Names:
  • SCH 503034
Biological: peginterferon alfa-2b
peginterferon alfa-2b 1.5 μg/kg/wk subcutaneously (SC)
Other Names:
  • PegIntron
Drug: Ribavirin
ribavirin (weight-based dosing) 800 to 1400 mg/day PO divided twice daily dose (BID).
PLACEBO_COMPARATOR: PBO + PR (Control)
Participants received PR for 4 weeks before addition of BOC-matched PBO. Participants then received BOC + PR for up to 44 weeks.
Biological: peginterferon alfa-2b
peginterferon alfa-2b 1.5 μg/kg/wk subcutaneously (SC)
Other Names:
  • PegIntron
Drug: Ribavirin
ribavirin (weight-based dosing) 800 to 1400 mg/day PO divided twice daily dose (BID).
Drug: Placebo
boceprevir-matched placebo four 200-mg capsules PO TID.
EXPERIMENTAL: Crossover Arm
Participants randomized to the PBO + PR Control arm who failed the futility rule at treatment week (TW) 12 or 24 were rolled over to the Crossover arm and received BOC + PR.
Drug: Boceprevir
boceprevir 200-mg capsules, 800 mg 3 times a day (TID), orally (PO)
Other Names:
  • SCH 503034
Biological: peginterferon alfa-2b
peginterferon alfa-2b 1.5 μg/kg/wk subcutaneously (SC)
Other Names:
  • PegIntron
Drug: Ribavirin
ribavirin (weight-based dosing) 800 to 1400 mg/day PO divided twice daily dose (BID).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Follow-up Week 24 (up to 72 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Follow-up Week 24 (up to 72 weeks)
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.
Treatment Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 23, 2011

Primary Completion (ACTUAL)

October 21, 2013

Study Completion (ACTUAL)

October 21, 2013

Study Registration Dates

First Submitted

August 26, 2011

First Submitted That Met QC Criteria

August 26, 2011

First Posted (ESTIMATE)

August 29, 2011

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2021

Last Update Submitted That Met QC Criteria

January 15, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P08160
  • MK-3034-046 (OTHER: Merck)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Study Data/Documents

  1. CSR Synopsis

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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