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

NCT01425203 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 238

Last updated 2021-02-08

Study results available
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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.

Conditions

  • Chronic Hepatitis C Genotype 1

Interventions

DRUG

Boceprevir

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

DRUG

Placebo

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

BIOLOGICAL

peginterferon alfa-2b

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

DRUG

Ribavirin

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

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-23
Primary Completion
2013-10-21
Completion
2013-10-21

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01425203 on ClinicalTrials.gov