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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02399345 | Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir Co-Administered With Sofosbuvir With and Without Ribavirin in Treatment-Naive HCV Genotype 1-Infected Adults | PHASE3 | COMPLETED | 10 | — | — | Mar 1, 2015 | Nov 1, 2015 | Dec 12, 2016 | - | — |
The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid \[HCV RNA\] level less than the lower limit of quantitation \[\< LLOQ\]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL.
| Arm | Type | Description |
|---|---|---|
| Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF plus RBV | EXPERIMENTAL | Ombitasvir/paritaprevir/ritonavir (ombitasvir/paritaprevir/r) (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) and sofosbuvir (SOF) (400 mg once daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 6 weeks. |
| Name | Type | Description |
|---|---|---|
| ombitasvir/paritaprevir/ritonavir, dasabuvir | DRUG | tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet |
| sofosbuvir (SOF) | DRUG | tablet |
| ribavirin (RBV) | DRUG | tablet |
Inclusion Criteria: 1. Male or female at least 18 years of age at time of screening 2. Chronic Hepatitis C virus (HCV) infection prior to study enrollment 3. Screening laboratory results from the central clinical laboratory indicating HCV genotype 1 infection only 4. Absence of cirrhosis and advanc...