NCT01653236

Boceprevir With Peginterferon Alfa-2b and Ribavirin in the Treatment-naive Patients Infected With Genotype 4 Chronic Hepatitis C Infection

Pilot Study to Determine the Efficacy and Safety of Combining Boceprevir With Peginterferon Alfa-2b and Ribavirin in the Treatment-naive Patients Infected With Genotype 4 Chronic Hepatitis C Infection

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Theodor Bilharz Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Hypothesis Combination of Boceprevir with Ribavirin in treatment-naïve patients with genotype 4 chronic hepatitis C infection will increase the proportion of patients achieving sustained viral response compared to standard treatment alone.

Detailed description

Objectives: The primary objective of this study is to assess the efficacy and safety of Boceprevir 800 mg three times per day (TID) orally (PO) (hereafter called Boceprevir) in combination with peginterferon alfa-2b 1.5 μg/kg once per week (QW) subcutaneously (SC) plus weight-based dosing (WBD) of ribavirin (800 to 1400 mg/day) compared to standard of care (SOC) (therapy with peginterferon alfa-2b (PEG)+ribavirin (RBV) WBD) in previously untreated adult subjects with chronic hepatitis C (CHC) genotype 4 infection. Primary Trial Objectives: \- The primary efficacy objective of this study is to assess the efficacy of Boceprevir in combination with PEG 1.5 μg/kg QW SC plus WBD of RBV (800 to 1400 mg/day) compared to the efficacy of SOC (therapy with PEG+RBV WBD) in the Control Arm in previously untreated adult subjects with CHC genotype 4 infection

Conditions

• Genotype 4 Chronic Hepatitis C Infection

Interventions

Type	Name	Description
DRUG	Boceprevir
DRUG	Peginterferon alfa-2b
DRUG	ribavirin

Timeline

• Start date: 2013-12-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2012-07-30
• Last updated: 2014-12-30

Locations

1 site across 1 country: Egypt