drugset / Trial / NCT01483742
A Study of Ritonavir-Boosted Danoprevir and RO5024048 in Different Combinations in Null Responder or Treatment-Naïve Patients With Chronic Hepatitis C and Compensated Cirrhosis
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This open-label, parallel cohort study will evaluate the safety, pharmacokinetics and antiviral activity of ritonavir-boosted danoprevir in combination with Pegasys (peginterferon alfa-2a) and ribavirin in treatment-naïve patients, and with RO5024048 added to the combination treatment in prior null responder patients with chronic hepatitis C genotype 1 or 4 and compensated cirrhosis. All patients will receive danoprevir 100 mg orally twice daily (bid) , ritonavir 100 mg orally bid, Pegasys 180 mcg subcutaneously weekly and ribavirin 1000-1200 mg/kg/day orally. Prior non-responders will receive RO5024048 1000 mg orally bid additionally. Anticipated time on study treatment is 24 weeks.
Timeline
- Start
- 2012-04
- Primary completion
- 2013-09
- Completion
- 2013-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | danoprevir | Small molecule | 100 mg | Oral |
| Subject | mericitabine | Small molecule | 1000 mg | Oral |
| Background | Peginterferon alfa-2a | Protein / enzyme biologic | 180 ug | Subcutaneous |
| Background | Ribavirin | Small molecule | 1000 mg/kg | Oral |
| Background | Ribavirin | Small molecule | 1200 mg/kg | Oral |
| Background | Ritonavir | Other / unclassified | 100 mg | Oral |