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Ribavirin · 1 trial · 1 indication
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...
Ribavirin is a small molecule being studied for the treatment of Chronic Hepatitis C. In a Phase 2 clinical trial, it was evaluated in combination with VX-950 and Pegasys, with and without Copegus, in patients with this condition. The trial has been completed.
Ribavirin is being developed by Vertex Pharmaceuticals Incorporated, which is publicly traded under the ticker VRTX. The company conducted a Phase 2 clinical trial of Ribavirin for Chronic Hepatitis C, which has been completed.
Ribavirin is in Phase 2 clinical development for Chronic Hepatitis C. It is an investigational drug and has not been approved by the FDA. The Phase 2 trial, which has been completed, enrolled 334 participants.
Ribavirin has one completed clinical trial, identified as NCT00372385. This Phase 2 study, titled 'Phase 2 Study of VX-950, Pegasys® With and Without Copegus® in Hepatitis C,' enrolled 334 patients with Chronic Hepatitis C across Austria, France, Germany, and the United Kingdom.
Ribavirin is not the same as Copegus. In the clinical trial NCT00372385, Ribavirin was studied in combination with VX-950 and Pegasys, with and without Copegus. Copegus is a separate medication used in the trial as part of the treatment regimen.