drugset / Trial / NCT00160251
Boceprevir (SCH 503034) Plus Peg-Intron, With and Without Added Ribavirin, in Patients With Chronic Hepatitis C, Genotype 1, Who Did Not Respond to Previous Treatment With Peginterferon Alfa Plus Ribavirin (Study P03659AM2)(COMPLETED)
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2005-09
- Primary completion
- 2007-07
- Completion
- 2007-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Boceprevir | Small molecule | 100 mg | Oral |
| Subject | Boceprevir | Small molecule | 200 mg | Oral |
| Subject | Boceprevir | Small molecule | 400 mg | Oral |
| Subject | Boceprevir | Small molecule | 800 mg | Oral |
| Subject | Ribavirin | Small molecule | 200 mg | Oral |
| Background | Peginterferon alfa-2b | Protein / enzyme biologic | 1.5 ug/kg | Subcutaneous |