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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01849562 | Safety, Tolerability, and Efficacy of 12-weeks of Sovaprevir, ACH-3102, and Ribavirin in Treatment-naive GT-1 HCV Participants | PHASE2 | COMPLETED | 30 | — | — | Apr 1, 2013 | Apr 1, 2014 | Aug 29, 2023 | - | — |
Incidence of SVR4 after the completion of dosing, reported as hepatitis C virus (HCV) ribonucleic acid less than the lower limit of quantification, in participants who received active treatment (sovaprevir and ACH-0143102 in combination with RBV) as compared to those who received placebo.
To determine the safety and tolerability of 12 weeks of sovaprevir/ACH-0143102/RBV treatment in participants with chronic genotype-1 (GT-1) HCV, the following criteria will be used: the number of participants with discontinuations due to adverse events (AEs), treatment-emergent Grade 3/Grade 4 (G3/G4) AEs, treatment-emergent G3/G4 laboratory abnormalities, and clinically significant electrocardiograms (ECGs).
| Arm | Type | Description |
|---|---|---|
| Sovaprevir 200 milligrams (mg), ACH-3102 150/50 mg, RBV 1000-1200 mg | ACTIVE_COMPARATOR | Sovaprevir 200 mg once daily (qd) + ACH-3102 150 mg loading dose on Day 1, followed by 50 mg qd + RBV weight-based 1000-1200 mg qd for 12 weeks. |
| Sovaprevir 400 mg, ACH-3102 150/50 mg, RBV 1000 -1200 mg | ACTIVE_COMPARATOR | Sovaprevir 400 mg qd + ACH-3102 150 mg loading dose on Day 1, followed by 50 mg qd + RBV weight-based 1000-1200 mg qd for 12 weeks. |
| Placebo | PLACEBO_COMPARATOR | Placebo for sovaprevir capsule qd + placebo for ACH-3102 150 mg loading dose on Day 1, followed by placebo for 50 mg qd + placebo for weight-based RBV qd for 12 weeks. |
| Name | Type | Description |
|---|---|---|
| Sovaprevir | DRUG | Nonstructural protein 3/4A protease inhibitor. |
| ACH-3102 | DRUG | Nonstructural protein 5A inhibitor. |
| Ribavirin | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: * Chronic HCV infection. * HCV GT-1. * HCV ribonucleic acid \> 10,000 international units/milliliter at screening. * Female participants must be willing to use 2 effective methods of contraception, one of which must be a barrier method, during the dosing period and 6 months afte...