NCT01446250

Alisporivir (Deb025) and Boceprevir Triple Therapies in African American Participants Not Previously Treated for Chronic Hepatitis C Genotype 1

A Randomized, Open Label Trial of the Safety and Efficacy of DEB025/Alisporivir in Combination With Pegylated Interferon-α2a and Ribavirin (Peg-INFα2a/RBV) and Boceprevir in Combination With Peg-INFα2a/RBV in African American Treatment-naïve Patients With Chronic Hepatitis C Genotype 1

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Debiopharm International SA · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the safety and efficacy of alisporivir (ALV) and boceprevir (BOC), each in combination with Peginterferon alfa-2a (PEG) and Ribavirin (RBV), in African American participants who have never received treatment for their chronic hepatitis C (HCV) genotype 1 infection.

Conditions

• Hepatitis C

Interventions

Type	Name	Description
DRUG	Alisporivir	ALV 200 mg soft gel capsules administered orally
DRUG	Boceprevir	BOC 800 mg (4 x 200 mg soft gel capsules) administered orally
DRUG	Peginterferon alfa-2a	PEG 180 μg administered via subcutaneous (s.c.) injection once weekly
DRUG	Ribavirin	RBV 200 mg tablets (weight-based dose: \< 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose

Timeline

• Start date: 2011-12-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2011-10-05
• Last updated: 2017-01-16
• Results posted: 2017-01-16

Locations

2 sites across 1 country: United States