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Safety and Efficacy of Boceprevir in Asia Pacific Participants With Chronic Hepatitis C Genotype 1 (P07063)

NCT01390844 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 282

Last updated 2018-09-11

Study results available
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Summary

This study will assess the efficacy of boceprevir (BOC) in combination with PegIntron (pegylated interferon alfa-2b) (PEG) and ribavirin (RBV) in response guided therapy compared to the efficacy of standard-of-care therapy alone in adult subjects with chronic hepatitis C (CHC) genotype 1 who failed prior treatment with pegylated interferon and RBV in the Asia Pacific population. The primary hypothesis is that the proportion of participants achieving sustained virologic response in the experimental therapy regimen (BOC/PEG+RBV) is superior to that in the control arm (Placebo/PEG+RBV), in the Full Analysis Set (FAS) population.

Conditions

  • Hepatitis C, Chronic

Interventions

DRUG

Boceprevir (BOC)

200 mg capsules, 800 mg three times daily by mouth

DRUG

Placebo to boceprevir

200 mg placebo capsules, 800 mg three times daily by mouth

DRUG

Peginterferon alfa-2b (PEG)

1.5 mcg/kg/week subcutaneously

DRUG

Ribavirin (RBV)

200 mg capsules, weight-based dosing 800 to 1400 mg/day by mouth divided twice daily

DRUG

Cross-Over Boceprevir Treatment

At Treatment Week 14, participants in the Placebo group with detectable HCV-RNA at Treatment Week 12 have the option to add boceprevir 800 mg three times daily to the PEG + RBV regimen for up to 32 weeks.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-21
Primary Completion
2015-06-19
Completion
2015-06-19

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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 NCT01390844 on ClinicalTrials.gov