At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 122 enrolled
Drug / intervention
ACH-0141625 (Sovaprevir) +5 moredrug
Likely dose
ACH-0141625 (Sovaprevir) 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating ACH-0141625 (Sovaprevir), Placebo, and 2 other interventions for Hepatitis C. Completed, enrolled 122 participants across 18 sites in 2 countries.
Detailed Summary
Evaluate safety, tolerability, and antiviral response of ACH-0141625 compared to standard of care in hepatitis C virus (HCV)-positive participants.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C
CountriesBelgium, United States
CollaboratorsAchillion, a wholly owned subsidiary of Alexion
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 2010
Enrollment StartSep 2010
Primary CompletionMar 2012
Study CompletionApr 2013
TodayJul 2026
First PostedAug 12, 2010
Enrollment StartSep 1, 2010
Primary CompletionMar 1, 2012
Study CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 15.9 years ago
Interventions
ACH-0141625 (Sovaprevir)drug
200 mg oral capsule once daily
ACH-0141625 (Sovaprevir)drug
400 mg oral capsule once daily
ACH-0141625 (Sovaprevir)drug
800 mg oral capsule once daily
Placebodrug
Powder in capsule once daily
Pegylated Interferon alpha-2adrug
180 micrograms (ug) once a week by subcutaneous injection
Ribavirindrug
400 mg or 600 mg (morning \[AM\]) and 600 mg (evening \[PM\]) capsules taken orally twice daily