Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pegylated Interferon/ribavirin · 1 trial · 1 indication
SVR is defined as nondetectable hepatitis C virus ribonucleic acid (HCV RNA) in plasma
| Arm | Type | Description |
|---|---|---|
| Pegylated interferon/ribavirin | ACTIVE_COMPARATOR | Pegasys - 180 mcg per 1.73 meter squared body surface area subcutaneously once weekly. Ribavirin - 15 mg per kg orally twice daily using 100-mg tablets. |
| Pegylated interferon/placebo | PLACEBO_COMPARATOR | Placebo tablets were supplied in the same dosing regimen as ribavirin, using the same number of tablets that would be given if ribavirin were being administered (eg, 3 placebo tablets twice daily for a 40-kg child who would receive 3 100-mg RV tablets twice daily). |
| Name | Type | Description |
|---|---|---|
| Pegylated Interferon/ribavirin | DRUG | - |
Inclusion Criteria: * Male or female patients who are 5-18 years of age at enrollment (not yet reached 18th birthday at screening). * HCV viremia (by any test) present on 2 tests separated by at least 6 months. * Chronic liver disease, as indicated by inflammation and/or fibrosis, consistent with c...