NCT01180790

Safety, Tolerability, and Antiviral Activity of ACH-0141625 or Placebo in Combination With Peginterferon and Ribavirin in Hepatitis C Virus (HCV) Positive Participants

A Phase IIa, Randomized, Double-blind (Participant and Investigator Blind, Sponsor Open), Placebo-controlled Trial to Evaluate the Safety, Tolerability, and Antiviral Activity of Oral ACH-0141625 in Combination With Pegylated Interferon Alpha-2a and Ribavirin in Two Segments, After 28 Days of Dosing and, Subsequently, After 12 Weeks of Dosing in Participants With Chronic Hepatitis C Virus Genotype 1

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Hepatitis C

Interventions

Type	Name	Description
DRUG	ACH-0141625 (Sovaprevir)	200 mg oral capsule once daily
DRUG	ACH-0141625 (Sovaprevir)	400 mg oral capsule once daily
DRUG	ACH-0141625 (Sovaprevir)	800 mg oral capsule once daily
DRUG	Placebo	Powder in capsule once daily
DRUG	Pegylated Interferon alpha-2a	180 micrograms (ug) once a week by subcutaneous injection
DRUG	Ribavirin	400 mg or 600 mg (morning \[AM\]) and 600 mg (evening \[PM\]) capsules taken orally twice daily

Timeline

• Start date: 2010-09-01
• Primary completion: 2012-03-01
• Completion: 2013-04-01
• First posted: 2010-08-12
• Last updated: 2023-08-30
• Results posted: 2014-09-10

Locations

18 sites across 2 countries: United States, Belgium