drugset / Trial / NCT01314261
Study of ABT-267 in Treatment Naive Hepatitis C Virus (HCV) Genotype 1 Infected Subjects
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study was to assess the safety, pharmacokinetics, and 4-week rapid virologic response (RVR) of 3 different doses of ABT-267 (also known as ombitasvir) in combination with pegylated interferon/ribavirin (pegIFN/RBV) compared with pegIFN/RBV alone (ABT-267 placebo) in treatment naïve, hepatitis C virus (HCV), genotype 1-infected participants.
Timeline
- Start
- 2011-03
- Primary completion
- 2012-01
- Completion
- 2013-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ombitasvir | Small molecule | 5 mg | — |
| Subject | ombitasvir | Small molecule | 50 mg | — |
| Subject | ombitasvir | Small molecule | 200 mg | — |
| Background | Peginterferon alfa-2a | Protein / enzyme biologic | 180 ug | Subcutaneous |
| Background | Ribavirin | Small molecule | 1000 mg | — |
| Background | Ribavirin | Small molecule | 1200 mg | — |