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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00372385 | Phase 2 Study of VX-950, Pegasys® With and Without Copegus® in Hepatitis C | PHASE2 | COMPLETED | 334 | — | — | Aug 1, 2006 | Jun 1, 2008 | Jul 23, 2014 | 4 | Austria, France +2 |
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).
| Arm | Type | Description |
|---|---|---|
| PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week | PLACEBO_COMPARATOR | Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\>=) 75 kg, for 48 weeks. |
| Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week | EXPERIMENTAL | Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet orally thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 weeks. |
| Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week | EXPERIMENTAL | Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 12 weeks. |
| Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week | EXPERIMENTAL | Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 12 weeks. |
| Name | Type | Description |
|---|---|---|
| Ribavirin | DRUG | tablet |
| Pegylated Interferon Alfa 2a | DRUG | Solution for injection |
| Placebo | DRUG | tablet |
| Telaprevir | DRUG | tablet |
Inclusion Criteria: * Hepatitis C virus Genotype 1 with detectable plasma hepatitis C virus RNA * Have been infected with Hepatitis C virus for greater than (\>) 6 months * Seronegative for hepatitis B surface antigen and human immunodeficiency virus 1 and 2 * Must agree to use 2 methods of contrac...