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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02250807 | Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Subjects With Chronic Genotype 4 Hepatitis C Virus Infection | PHASE3 | COMPLETED | 40 | — | — | Jan 1, 2015 | Dec 1, 2015 | Nov 17, 2016 | 6 | Spain |
SVR12 is defined as the percentage of participants with hepatitis C virus ribonucleic acid (HCV RNA) less than (\<) lower limit of quantification (LLOQ; 15 international unit per milliliter \[IU/mL\]) detectable or undetectable 12 weeks after actual EOT.
| Arm | Type | Description |
|---|---|---|
| Simeprevir and Sofosbuvir | EXPERIMENTAL | Subjects will receive oral capsule of Simeprevir 150 milligram (mg) along with oral tablet of sofosbuvir 400 mg, once a day from Day 1 up to Week 12. |
| Name | Type | Description |
|---|---|---|
| Simeprevir | DRUG | Subjects will receive oral capsule of Simeprevir 150 mg, once a day from Day 1 up to Week 12. |
| Sofosbuvir | DRUG | Subjects will receive oral tablet of sofosbuvir 400 mg, once a day from Day 1 up to Week 12. |
Inclusion Criteria: * Subjects with confirmed hepatitis C virus (HCV) with HCV RNA greater than (\>) 10000 international unit per milliliter (IU/mL) * Subjects who are treatment naive or treatment-experienced. * Subjects must have documentation of a liver biopsy or fibroscan or agree to have one du...