At a glance
ClinicalIndex Comparison Record- ✓Documented chronic hepatitis C infection, genotype 1
- ✓Documented treatment failure to peginterferon-alfa plus ribavirin (defined as less than 2 log drop in HCV-RNA after 12 weeks or never achieving HCV-RNA negativity)
- ✓No evidence of cirrhosis on liver biopsy
- ✓Physical examination and laboratory test results within specified ranges
- ✕Pregnancy or nursing
- ✕Cirrhosis
- ✕Co-infection with Hepatitis B or HIV
- ✕Previous treatment with any HCV polymerase or protease inhibitor
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
PEG-Intron/REBETOL vs PEG-Intron/ SCH 503034 With and Without Ribavirin in Chronic Hepatitis C Virus Genotype 1 (HCV-1) Peginterferon Alfa/Ribavirin Nonresponders: A SCH 503034 Dose-Finding Phase 2 Study
In Brief
A Phase 2 clinical trial evaluating Boceprevir (BOC), PegIntron (PEG), and 1 other intervention for Chronic Hepatitis C. Completed, enrolled 357 participants.
Detailed Summary
The primary objective of this study is to determine the safe and effective dose range of boceprevir (SCH 503034) in combination with PEG-Intron in adult subjects who have chronic hepatitis C without cirrhosis, and who have failed an adequate course of combination therapy with peginterferon-alfa plus ribavirin. A secondary objective is to explore whether ribavirin provides an additional benefit when combined with PEG-Intron plus boceprevir.
Study Details
Timeline
Interventions
100 or 200 mg capusles taken orally as 100 mg, 200 mg, 400 mg, or 800 mg TID
1.5 mcg/kg weekly subcutaneously
200 mg capsules taken twice daily (BID) (total daily dose of 800-1400 mg/day, depending on weight \[weight-based dosing {WBD}\])