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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02292719 | A Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir With Sofosbuvir With or Without Ribavirin in Adults With Chronic Hepatitis C Virus Infection | PHASE2 | COMPLETED | 70 | — | — | Dec 19, 2014 | Jul 14, 2017 | Jul 12, 2021 | - | — |
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \[\<LLOQ\]) 12 weeks after the last dose of study drug.
| Arm | Type | Description |
|---|---|---|
| Arm A (genotype [GT]3, noncirrhotic) | EXPERIMENTAL | Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) 25/150/100 mg once daily (QD) and sofosbuvir (SOF) 400 mg QD for 12 weeks. |
| Arm B (GT3, noncirrhotic) | EXPERIMENTAL | OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and ribavirin (RBV; weight-based 1,000 mg or 1,200 mg daily divided twice daily \[BID\]) for 12 weeks. |
| Arm C (GT2, noncirrhotic) | EXPERIMENTAL | OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight- based 1,000 mg or 1,200 mg daily divided BID) for 8 weeks. |
| Arm D (GT2, noncirrhotic) | EXPERIMENTAL | OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 6 weeks. |
| Arm E (GT3, cirrhotic) | EXPERIMENTAL | OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 12 weeks. |
| Arm F (GT3, noncirrhotic) | EXPERIMENTAL | OBV/PTV/r (25/150/100) mg QD and SOF (400 mg QD) for 12 weeks. |
| Name | Type | Description |
|---|---|---|
| OBV/PTV/r | DRUG | Tablet |
| Sofosbuvir | DRUG | Tablet |
| Ribavirin (RBV) | DRUG | Tablet |
Inclusion Criteria: 1. Chronic HCV infection prior to study enrollment. 2. Screening laboratory results from the central clinical laboratory indicating HCV genotype 2 or 3 infection only (no mixed genotype). 3. Absence OR presence of cirrhosis. 4. If cirrhotic, need to have compensated cirrhosis an...