Conditions: Hepatitis C
Keywords: HCV Hepatitis C Genotype 1
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 122
Healthy volunteers: no

Brief summary:
Evaluate safety, tolerability, and antiviral response of ACH-0141625 compared to standard of care in hepatitis C virus (HCV)-positive participants.

Detailed description:

Arms:
arm 1: 200 mg ACH-0141625 for 28 days plus pegylated interferon (Peg-IFN) alpha-2a and ribavirin (RBV) for 48 weeks arm 2: 400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks arm 3: 800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks arm 4: Placebo for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks arm 5: 200 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks arm 6: 400 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks arm 7: 800 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks

Interventions: intervention 1: ACH-0141625 (Sovaprevir) intervention 2: ACH-0141625 (Sovaprevir) intervention 3: ACH-0141625 (Sovaprevir) intervention 4: Placebo intervention 5: Pegylated Interferon alpha-2a intervention 6: Ribavirin
Intervention descriptions: intervention 1: 200 mg oral capsule once daily intervention 2: 400 mg oral capsule once daily intervention 3: 800 mg oral capsule once daily intervention 4: Powder in capsule once daily intervention 5: 180 micrograms (ug) once a week by subcutaneous injection intervention 6: 400 mg or 600 mg (morning \[AM\]) and 600 mg (evening \[PM\]) capsules taken orally twice daily

Protocol document: