drugset / Trial / NCT00446134
Taribavirin Phase 2 Dose Finding Study for the Treatment of Hepatitis C Virus (HCV)
RandomizedParallel-groupOpen-labelTreatment
Summary
The objective of the study is to select an optimal dose of taribavirin by comparing the efficacy and safety of 3 taribavirin dose levels, 20, 25, and 30 mg/kg/day, versus ribavirin 800 to 1400 mg/day based on body weight, both administered in combination with peginterferon alfa-2b to therapy-naive patients with chronic Hepatitis C Virus (HCV) genotype 1 infection.
Timeline
- Start
- 2007-03
- Primary completion
- 2008-04
- Completion
- 2009-04
Publications
- Results Poordad F, Lawitz E, Pozza R, et al. Efficacy and safety of weight-based regimens of taribavirin or ribavirin, given with peginterferon alfa-2b, 12 weeks after treatment (SVR12) in naive patients with genotype 1 hepatitis C. J Hepatol. 2009;50 Suppl 1:S8
- Results Poordad F, Lawitz E, Shiffman ML, Hassanein T, Muir AJ, Bacon BR, Heise J, Halliman D, Chun E, Hammond J. Virologic response rates of weight-based taribavirin versus ribavirin in treatment-naive patients with genotype 1 chronic hepatitis C. Hepatology. 2010 Oct;52(4):1208-15. doi: 10.1002/hep.23827.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ribavirin | Small molecule | 800 mg | Oral |
| Subject | Ribavirin | Small molecule | 1000 mg | Oral |
| Subject | Ribavirin | Small molecule | 1200 mg | Oral |
| Subject | Ribavirin | Small molecule | 1400 mg | Oral |
| Subject | Taribavirin | Small molecule | 20 mg/kg | Oral |
| Subject | Taribavirin | Small molecule | 25 mg/kg | Oral |
| Subject | Taribavirin | Small molecule | 30 mg/kg | Oral |