A study of mericitabine in combination with boceprevir and Pegasys/Copegus in patients with chronic hepatitis C (clinicaltrials.gov) - Sep 17, 2012 - P2, N=60; Sponsor: Hoffmann-La Roche; Recruiting; N=100 -> 60; Change: No. of arms 3 -> 2
Clinical protocol • Enrollment change • Hepatitis C Virus
|
|
This study is currently recruiting participants.
Verified September 2012 by Hoffmann-La Roche
Sponsor: Hoffmann-La Roche
Information provided by (Responsible Party): Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01482403
First received: November 28, 2011
Last updated: September 17, 2012
Last verified: September 2012
History of Changes
Purpose
This randomized, double-blind, multi-center, placebo-controlled, parallel-group study will evaluate the sustained virologic response and the safety of mericitabine (RO5024048) in combination with boceprevir and Pegasys/Copegus in patients with chronic hepatitis C infection. The anticipated time on study treatment is up to 48 weeks.
Condition
Hepatitis C, Chronic
Intervention
Drug: mericitabine
Drug: boceprevir
Drug: Pegasys
Drug: Copegus
Phase
Phase 2
Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A PHASE II, RANDOMIZED, DOUBLE-BLIND, MULTICENTER, PARALLEL GROUP STUDY TO EVALUATE THE SUSTAINED VIROLOGIC RESPONSE OF THE HCV POLYMERASE INHIBITOR PRODRUG RO5024048 IN COMBINATION WITH BOCEPREVIR AND PEGASYS®/COPEGUS® IN PATIENTS WITH CHRONIC HEPATITIS C GENOTYPE 1 VIRUS INFECTION WHO WERE PRIOR NULL RESPONDERS TO TREATMENT WITH PEGYLATED INTERFERON/RIBAVIRIN
Resource links provided by NLM:
MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C
Drug Information available for: Ribavirin Peginterferon Alfa-2a Boceprevir
U.S. FDA Resources
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
Sustained virological response 12 weeks after treatment (SVR-12) [ Time Frame: up to 60 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
Sustained virological response 4 weeks after treatment [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
Virologic response over time [ Time Frame: 60 weeks ] [ Designated as safety issue: No ]
Proportion of patients who develop treatment resistance [ Time Frame: 60 weeks ] [ Designated as safety issue: No ]
Safety (incidence of adverse events) [ Time Frame: 60 weeks ] [ Designated as safety issue: No ]
Pharmacokinetics: trough concentration of RO4995855 [ Time Frame: Day 1 and Week 8 ] [ Designated as safety issue: No ]
Pharmacokinetics: trough concentration of RO5012433 [ Time Frame: Day 1 and Week 8 ] [ Designated as safety issue: No ]
Pharmacokinetics: trough concentration of boceprevir [ Time Frame: Day 1 and Week 8 ] [ Designated as safety issue: No ]
Estimated Enrollment: 60
Study Start Date: November 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
IR6
|