Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Taribavirin Dose-Finding in Chronic HCV Genotype 1
NCT00446134Phase 2
Key facts
- Status
- Completed
- Start
- Mar 2007
- Primary completion
- Apr 2008
- Countries
- 1
- Sponsor
- Valeant Pharmaceuticals
- Modality
- Orthosteric Ligands, Metabolically Activated Prodrugs
- Drugs
- taribavirin
- Conditions
- hepatitis C (HCV)
01
Overview
Phase 2, randomised trial of taribavirin in hepatitis C (HCV) (4 arms), sponsored by Valeant Pharmaceuticals. Primary endpoint: Early Virologic Response at 12 weeks. Started Mar 2007; status: completed.
02
Design
4 arms- Study design
- Randomized
Taribavirin 20 mg/kg
Taribavirin 20 mg/kg/day BID + PEG-IFN
Taribavirin 25 mg/kg
Taribavirin 25 mg/kg/day BID + PEG-IFN
Taribavirin 30 mg/kg
Taribavirin 30 mg/kg/day BID + PEG-IFN
Ribavirin Control
Ribavirin 800-1400 mg/day BID + PEG-IFN
03
Who it enrols
Patients with chronic HCV genotype 1, treatment-naive, with no cirrhosis (F4 excluded) and adequate hematologic/renal function.
04
Endpoints
Primary
Early Virologic Response
Secondary
Incidence of Anemia
Sustained Virologic Response
Relapsers at Follow-Up
05
Results
Primary endpoints met
Beyond the preview
Go deeper on NCT00446134.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT00446134.