ACH-0141625 (Sovaprevir)
Drug200 mg oral capsule once daily
NCT Number: NCT01180790
Evaluate safety, tolerability, and antiviral response of ACH-0141625 compared to standard of care in hepatitis C virus (HCV)-positive participants.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 2
Clinical Trial Site, Edegem, Antwerp, Belgium
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
200 mg oral capsule once daily
Powder in capsule once daily
180 micrograms (ug) once a week by subcutaneous injection
Other names: Peg-INF
400 mg or 600 mg (morning [AM]) and 600 mg (evening [PM]) capsules taken orally twice daily
Other names: Ribasphere, Copegus
Time frame: 4 weeks
Segment 1: Percentage of participants with the following: adverse events, abnormal laboratory safety tests, dose reductions, interruptions, and discontinuations. Criteria for abnormal laboratory safety tests: treatment-emergent worsening Division of AIDS (Acquired Immunodeficiency Syndrome) (DAIDs) graded laboratory tests. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Time frame: 4 weeks
The primary efficacy endpoint for Segment 1 of the study was the percentage of participants in each treatment group achieving RVR4 (hepatitis C virus [HCV] ribonucleic acid (RNA) less than or equal to the limit of quantitation [LOQ] at the Week 4 visit).
Time frame: 12 weeks
Segment 2: Percentage of participants with the following: adverse events, abnormal laboratory safety tests and dose reductions, interruptions and discontinuations. Criteria for abnormal laboratory safety tests: treatment-emergent worsening DAIDs graded laboratory tests. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Time frame: Week 12
The primary efficacy endpoint for Segment 2 of the study was the percentage of participants achieving cEVR, defined as undetectable HCV RNA at Week 12.
Time frame: 12 weeks
For Segment 1, the percentage of participants in the virology population who achieved cEVR, defined as undetectable HCV RNA at Week 12.
Time frame: 4 weeks
For Segment 2, the percentage of participants in the virology population who achieved RVR4, defined as HCV RNA less than or equal to the LOQ at the Week 4 visit.
Time frame: Week 48 (Segment 1); Week 24 (Segment 2)
The percentage of virology population participants who were reported as undetectable HCV RNA at the completion of treatment.
Time frame: 3 months post-dosing
The percentage of virology population participants who achieved sustained virologic response (SVR), defined as HCV RNA less than the LOQ, at 12 weeks (3 months) post-dosing.
Time frame: 6 months post-dosing
The percentage of virology population participants who achieved SVR, defined as HCV RNA less than the LOQ, 6 months post-dosing.
Time frame: Week 4
The mean change from baseline in log10 HCV RNA level by visit for the virology population
Time frame: Week 12
Change from baseline in log10 HCV RNA level by visit.
Alexion Pharmaceuticals, Inc.
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03935906
Blood-Borne Infections, Communicable Diseases
Melbourne, Australia
View Trial DetailsNCT00004850
Blood-Borne Infections, Communicable Diseases
Bethesda, Maryland, United States
View Trial DetailsNCT05208697
Blood-Borne Infections, Communicable Diseases
Fort Lauderdale, Florida, United States
View Trial DetailsNCT03222531
Blood-Borne Infections, Cardiac Transplant
Pittsburgh, Pennsylvania, United States
View Trial Details