drugset / Trial / NCT01260350
Open-Labeled Study of PSI-7977 and RBV With and Without PEG-IFN in Treatment-Naïve Patients With HCV GT2 or GT3
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is to assess the safety and tolerability of sofosbuvir (SOF) 400 mg with and without ribavirin (RBV) and/or with and without pegylated interferon alfa-2a (PEG) in subjects with genotype 1, 2 or 3 hepatitis C (HCV) infection.
Timeline
- Start
- 2010-12
- Primary completion
- 2013-10
- Completion
- 2013-12
Publications
- Results Gane EJ, Stedman CA, Hyland RH, Ding X, Svarovskaia E, Subramanian GM, Symonds WT, McHutchison JG, Pang PS. Efficacy of nucleotide polymerase inhibitor sofosbuvir plus the NS5A inhibitor ledipasvir or the NS5B non-nucleoside inhibitor GS-9669 against HCV genotype 1 infection. Gastroenterology. 2014 Mar;146(3):736-743.e1. doi: 10.1053/j.gastro.2013.11.007. Epub 2013 Nov 18.
- Results Gane EJ, Stedman CA, Hyland RH, Ding X, Svarovskaia E, Symonds WT, Hindes RG, Berrey MM. Nucleotide polymerase inhibitor sofosbuvir plus ribavirin for hepatitis C. N Engl J Med. 2013 Jan 3;368(1):34-44. doi: 10.1056/NEJMoa1208953.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | LDV/SOF | Unknown | 90 mg | — |
| Subject | LDV/SOF | Unknown | 400 mg | — |
| Subject | Ledipasvir | Small molecule | 90 mg | — |
| Subject | Peginterferon alfa-2a | Protein / enzyme biologic | 180 ug | Subcutaneous |
| Subject | RADALBUVIR | Small molecule | 500 mg | Oral |
| Subject | Ribavirin | Small molecule | 800 mg | Oral |
| Subject | Ribavirin | Small molecule | 1000 mg | Oral |
| Subject | Ribavirin | Small molecule | 1200 mg | Oral |
| Subject | Sofosbuvir | Small molecule | 400 mg | Oral |