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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01241760 | VX-950-C211 - A Dosing Regimen Study (Twice Daily Versus Every 8 Hours) of Telaprevir in Treatment-naïve Participants With Genotype 1 Chronic Hepatitis C Virus Infection | PHASE3 | COMPLETED | 744 | — | — | Dec 1, 2010 | Nov 1, 2012 | Jun 4, 2014 | 99 | United States, Australia +11 |
The table below shows the percentage of participants achieving Sustained Virologic Response 12 weeks after last planned dose of study medication (SVR12 planned). SVR was defined as having Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 international units/milliliter (IU/mL).
| Arm | Type | Description |
|---|---|---|
| 001 T(q8h) / PR | EXPERIMENTAL | Telaprevir (T) 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (P) and ribavirin (R) |
| 002 T(b.i.d.) / PR | EXPERIMENTAL | Telaprevir (T) 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (P) and ribavirin (R) |
| Name | Type | Description |
|---|---|---|
| Ribavirin | DRUG | Ribavirin (RBV) 1000-1200 milligram (mg) per day (weight dependent) twice daily regimen oral tablets for 24 or 48 weeks depending on the patient's treatment response at week 4 |
| Telaprevir | DRUG | 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks |
| Pegylated interferon alfa-2a | DRUG | 180 microgram (µg) per week, subcutaneous injection, for 24 or 48 weeks Pegylated interferon alfa-2a 180 microgram (µg) per week subcutaneous injection for 24 or 48 weeks depending on the patient's treatment response at week 4 |
Inclusion Criteria: * Patient has chronic HCV infection genotype 1 with HCV RNA level \> 1,000 IU/mL * Patients should not have had any previous treatment for hepatitis C * Patient must have documentation of a liver biopsy within 2 years before the screening visit or the patient must agree to have ...