NCT01591460

A Triple Combination Therapy Study of Boceprevir, Pegasys and Copegus in Previously Untreated Patients With Genotype 1 Chronic Hepatitis C

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 165 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	boceprevir	800 mg three times daily for 24, 32 or 44 weeks
DRUG	peginterferon alfa-2a [Pegasys]	180 mcg subcutaneously once a week for 24, 32 or 44 weeks
DRUG	peginterferon alfa-2a [Pegasys]	180 mcg subcutaneously once a week for 4 weeks
DRUG	ribavirin (Copegus]	1000 mg or 1200 mg orally once a day for 24, 32 or 44 weeks
DRUG	ribavirin (Copegus]	1000 mg or 1200 mg orally once a day for 4 weeks

Timeline

• Start date: 2012-08-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2012-05-04
• Last updated: 2016-11-02
• Results posted: 2015-08-07

Locations

32 sites across 6 countries: Austria, Germany, Hungary, Poland, Romania, Spain