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Boceprevir in Subjects With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Peginterferon/Ribavirin (Study P05101AM3)(COMPLETED)

NCT00708500 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 404

Last updated 2017-04-07

Study results available
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Summary

This study involves treatment with boceprevir or placebo in combination with pegylated interferon alfa-2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing \[WBD\]) in adult subjects with chronic hepatitis C (CHC) genotype 1 who demonstrated interferon responsiveness (a decrease in hepatitis C virus RNA \[HCV-RNA\] viral load \>=2 log10 by Week 12 or undetectable HCV-RNA at end of treatment) but who failed to achieve sustained virologic response (SVR) on prior treatment with any combination therapy of peginterferon alpha and RBV. This trial includes three arms, one control arm (PEG2b + RBV for 48 weeks) and two experimental arms (PEG2b + RBV + boceprevir). One of the experimental arms, Arm 3, consists of treatment with all three drugs for 44 weeks after the lead-in. The other experimental arm, Arm 2, consists of all three drugs for 32 weeks after the lead-in. Participants in Arm 2 who were undetectable for HCV-RNA at Treatment Week 8 will complete treatment at that point. Those who were not undetectable for HCV-RNA at Treatment Week 8 will receive an additional 12 weeks of PEG2b + RBV + boceprevir placebo. It is hypothesized that the addition of a third active anti-HCV drug may lead to more rapid viral response than therapy with two drugs, and therefore, the addition of boceprevir to PEG2b plus RBV therapy after a 4-week lead-in period may allow for both increased rates of SVR and shorter treatment durations (in some populations) than treatment with peginterferon plus RBV alone.

Conditions

  • Hepatitis C, Chronic

Interventions

DRUG

Boceprevir (SCH 503034)

Boceprevir, 200 mg capsules, 800 mg TID PO

BIOLOGICAL

Pegylated interferon alfa-2b (SCH 54031)

PEG2b 1.5 μg/kg/week subcutaneously (SC)

DRUG

Ribavirin (SCH 18908)

Ribavirin WBD 600 mg/day to 1400 mg/day by mouth (PO) divided twice daily (BID).

DRUG

Boceprevir placebo

Boceprevir placebo, 200 mg capsules, 800 mg three times daily (TID) PO.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2010-04-30
Completion
2010-04-30

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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 NCT00708500 on ClinicalTrials.gov