Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01180790 | Safety, Tolerability, and Antiviral Activity of ACH-0141625 or Placebo in Combination With Peginterferon and Ribavirin in Hepatitis C Virus (HCV) Positive Participants | PHASE2 | COMPLETED | 122 | — | — | Sep 1, 2010 | Apr 1, 2013 | Aug 30, 2023 | 18 | United States, Belgium |
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.
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).
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.
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.
| Arm | Type | Description |
|---|---|---|
| Segment 1: 200 milligrams (mg) ACH-0141625 | EXPERIMENTAL | 200 mg ACH-0141625 for 28 days plus pegylated interferon (Peg-IFN) alpha-2a and ribavirin (RBV) for 48 weeks |
| Segment 1: 400 mg ACH-0141625 | EXPERIMENTAL | 400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks |
| Segment 1: 800 mg ACH-0141625 | EXPERIMENTAL | 800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks |
| Segment 1: Placebo | PLACEBO_COMPARATOR | Placebo for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks |
| Segment 2: 200 mg ACH-0141625 | EXPERIMENTAL | 200 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks |
| Segment 2 : 400 mg ACH-0141625 | EXPERIMENTAL | 400 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks |
| Segment 2 : 800 mg ACH-0141625 | EXPERIMENTAL | 800 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks |
| Name | Type | Description |
|---|---|---|
| ACH-0141625 (Sovaprevir) | DRUG | 200 mg oral capsule once daily |
| Placebo | DRUG | Powder in capsule once daily |
| Pegylated Interferon alpha-2a | DRUG | 180 micrograms (ug) once a week by subcutaneous injection |
| Ribavirin | DRUG | 400 mg or 600 mg (morning \[AM\]) and 600 mg (evening \[PM\]) capsules taken orally twice daily |
Inclusion Criteria: * Males and females, aged 18 years and older * Chronic hepatitis C genotype 1 (as specified in the protocol) * Treatment naive * Females who are post-menopausal and amenorrheic must have a follicle-stimulating hormone (FSH) at screening. Females of childbearing potential must ha...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Atea Pharmaceuticals, Inc. | AVIR | 2 | PHASE3 | Bemnifosbuvir-Ruzasvir, Sofosbuvir-Velpatasvir |
| Abbott Laboratories | ABT | 2 | — | Undisclosed |
| AbbVie, Inc. | ABBV | 1 | — | Undisclosed |