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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02692703 | A Study to Evaluate the Safety and Efficacy of ABT-493/ABT-530 in Adult Post-Liver or Post-Renal Transplant Recipients With Chronic Hepatitis C Virus (MAGELLAN-2) | PHASE3 | COMPLETED | 100 | — | — | Apr 22, 2016 | Jun 29, 2017 | Jul 13, 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. The primary efficacy endpoint was noninferiority of the percentage of participants who achieved SVR12 compared with the historical SVR12 rate for the current standard of care regimens (sofosbuvir \[SOF\]/ledipasvir \[LDV\] + ribavirin \[RBV\] OR SOF + daclatasvir \[DCV\] + RBV). Participants with missing data after backward imputation were counted as non-responders.
| Arm | Type | Description |
|---|---|---|
| Glecaprevir/Pibrentasvir | EXPERIMENTAL | Glecaprevir/pibrentasvir (300 mg/120 mg) coformulated once daily (QD) for 12 weeks. |
| Name | Type | Description |
|---|---|---|
| glecaprevir/pibrentasvir | DRUG | Tablet; glecaprevir coformulated with pibrentasvir |
Inclusion Criteria: * Male or female, at least 18 years of age at time of screening. * Screening laboratory result indicating hepatitis C virus (HCV) genotype 1-6 (GT1-6) infection. * Subject is a recipient of a cadaveric or living donor liver transplant which was a consequence of HCV infection at ...