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An International, Multicenter, Open-Label Study Evaluating Sustained Virological Response and Safety With Boceprevir in Triple Combination Therapy With Peginterferon Alfa-2a (40KD) and Ribavirin in Treatment-Naïve Patients With Genotype 1 Chronic Hepatitis C
This open-label, multicenter, treatment response guided study will evaluate the sustained virological response and safety of the triple combination therapy boceprevir, Pegasys (peginterferon alfa-2a) and Copegus (Ribavirin) in previously untreated patients with genotype 1 chronic hepatitis C. In the lead-in phase, patients will receive a dual combination therapy of Pegasys and Copegus for 4 weeks. In the following triple combination therapy phase, 800 mg boceprevir, 180 mcg Pegasys and 1000-1200 mg Copegus will be administered for 24, 32 or 44 weeks; the duration depending on the patient's treatment response. The anticipated time on study treatment is up to 48 weeks.
Details
| Lead sponsor | Hoffmann-La Roche |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 165 |
| Start date | 2012-08 |
| Completion | 2014-06 |
Conditions
- Hepatitis C, Chronic
Interventions
- boceprevir
- peginterferon alfa-2a [Pegasys]
- peginterferon alfa-2a [Pegasys]
- ribavirin (Copegus]
- ribavirin (Copegus]
Primary outcomes
- Percentage of Participants With Sustained Virological Response (SVR) at 12 Weeks After End of Treatment (EOT) — At 12 weeks after EOT (up to 60 weeks)
SVR at 12 weeks after EOT was defined as an undetectable HCV RNA viral load obtained 12 weeks following completion of treatment. HCV RNA viral load was measured using the Roche COBAS TaqMan 2.0 HCV Test, with a lower limit of detection (LOD) of 10 to 15 international units per milliliter (IU/mL). The percentage of participants with SVR was calculated as \[number of participants with undetectable HCV RNA at 12 weeks after EOT divided by the number of participants analyzed\] multiplied by 100.
Countries
Austria, Germany, Hungary, Poland, Romania, Spain