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Safety and Efficacy of SCH 503034 in Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 (Study P03523)

NCT00423670 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 765

Last updated 2017-04-05

Study results available
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Summary

This was an open-label, randomized safety and efficacy trial in adult, treatment-naïve Chronic Hepatitis C (CHC) participants with genotype 1 infection. The study conducted in 2 parts, compared standard-of-care PegIntron (1.5 μg/kg, once weekly \[QW\]), plus ribavirin (800 to 1400 mg/day), for 48 weeks to five treatment paradigms containing boceprevir (SCH 503034) 800 mg thrice a day (TID). The five treatments included boceprevir (BOC) plus standard-of-care for 28 or 48 weeks, with and without a 4-week lead-in with PegIntron (PEG) and ribavirin (RBV), and exploration of PegIntron plus low-dose ribavirin (400 to 1000 mg/day) plus boceprevir for 48 weeks.

Conditions

  • Chronic Hepatitis C

Interventions

DRUG

boceprevir (SCH 503034)

200 mg capsules taken as 800 mg orally three times daily (TID)

DRUG

peginterferon-alfa 2b (PegIntron)

1.5 μg/kg subcutaneously (SC) once weekly (QW)

DRUG

ribavirin

200 mg capsules in doses of 800 to 1400 mg/day (based on weight) taken orally divided twice daily

DRUG

ribavirin (low-dose)

200 mg capsules in doses of 400 to 1000 mg/day (based on weight) taken orally divided twice daily

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2008-08-31
Completion
2008-11-30

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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 NCT00423670 on ClinicalTrials.gov