NCT00910624

Boceprevir Treatment in Participants With Chronic Hepatitis C Genotype 1 Deemed Nonresponders to Peginterferon/Ribavirin (P05514)

A Single-Arm Study to Provide Boceprevir Treatment in Subjects With Chronic Hepatitis C Genotype 1 Deemed Nonresponders to Peginterferon/Ribavirin in Previous Schering-Plough Boceprevir Studies

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 168 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, multicenter study of boceprevir (BOC) in combination with peginterferon plus ribavirin (PEG/RBV) in adult chronic hepatitis C (CHC) genotype 1 participants who completed their per-protocol defined treatment and did not achieve sustained viral response (SVR) while in the PEG/RBV control arm(s) of an Schering-Plough Research Institute (SPRI) study of BOC combination therapy. Participants who are able to enroll in this study within 2 weeks after the last dose of PEG/RBV in previous protocol are to receive BOC+ PEG/RBV for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who are not able to enroll in this study within 2 weeks after the last dose of PEG/RBV in previous protocol are to receive PEG/RBV for 4 weeks followed by BOC+ PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	Boceprevir	Boceprevir, 200-mg capsules, 800 mg three times a day (TID) orally (PO)
BIOLOGICAL	Peginterferon alfa-2b (SCH 54031)	Peginterferon alfa-2b 1.5 µg/kg/week subcutaneously (SC)
DRUG	Ribavirin (SCH 18908)	Ribavirin weight-based dosing (WBD) 600 mg/day to 1400 mg/day PO divided twice daily (BID).

Timeline

• Start date: 2009-06-22
• Primary completion: 2012-12-07
• Completion: 2012-12-07
• First posted: 2009-06-01
• Last updated: 2021-02-08
• Results posted: 2013-11-19