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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02265237 | A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir Co-administered With Ribavirin (RBV) in Adults With Genotype 4 Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (AGATE-1) | PHASE3 | COMPLETED | 184 | — | — | Oct 28, 2014 | Apr 7, 2017 | Aug 31, 2017 | - | — |
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 | EXPERIMENTAL | Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 12 weeks for genotype 4 treatment-naïve or treatment-experienced with IFN/RBV. |
| Arm B | EXPERIMENTAL | Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 16 weeks for genotype 4 treatment-naive or treatment-experienced with IFN/RBV. |
| Arm C | EXPERIMENTAL | Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 treatment-naive and treatment-experienced with IFN/RBV. |
| Arm D | EXPERIMENTAL | Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 SOF/pegIFN/RBV or SOF/RBV treatment-experienced. |
| Name | Type | Description |
|---|---|---|
| ombitasvir/paritaprevir/ritonavir | DRUG | tablets |
| ribavirin | DRUG | tablets |
Inclusion Criteria: For Arms A, B and C: \- Participants must meet one of the following: * Treatment-naive: Participant has never received antiviral treatment for hepatitis C infection OR * Treatment Experienced (Prior null responders, Partial responders or Relapsers to IFN/RBV); For Arm D: \- ...