Safety, Tolerability, and Antiviral Activity of ACH-0141625 or Placebo in Combination With Peginterferon and Ribavirin in Hepatitis C Virus (HCV) Positive Participants
Summary
Evaluate safety, tolerability, and antiviral response of ACH-0141625 compared to standard of care in hepatitis C virus (HCV)-positive participants.
Timeline
- Start
- 2010-09
- Primary completion
- 2012-03
- Completion
- 2013-04
Outcome
Mixed primary results
registry Segment 1: Placebo vs Segment 1: 200 mg ACH-0141625 vs Segment 1: 400 mg ACH-0141625 vs Segment 1: 800 mg ACH-0141625; p = 0.003; exact Cochran-Armitage test NCT01180790 ↗
registry Segment 1: Placebo: Rapid Virologic Response (%): 20.0 percentage of participants NCT01180790 ↗
registry Segment 1: 200 mg ACH-0141625: Rapid Virologic Response (%): 75.0 percentage of participants NCT01180790 ↗
registry Segment 2: 200 mg ACH-0141625 vs Segment 2: 400 mg ACH-0141625 vs Segment 2: 800 mg ACH-0141625; p = 0.34; Exact Cochran-Armitage test NCT01180790 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sovaprevir | Small molecule | 200 mg | Oral |
| Subject | Sovaprevir | Small molecule | 400 mg | Oral |
| Subject | Sovaprevir | Small molecule | 800 mg | Oral |
| Background | Peginterferon alfa-2a | Protein / enzyme biologic | 180 ug | Subcutaneous |
| Background | Ribavirin | Small molecule | 400 mg | Oral |
| Background | Ribavirin | Small molecule | 600 mg | Oral |