NCT00803309

Study to Assess the Efficacy of 12 Versus 24 Weeks of Extended Treatment in HCV-Genotype 2/3 Patients

Optimization of Treatment for Patients With Chronic Hepatitis C Infected With HCV-genotype 2 or 3: 12 vs. 24 Weeks of Treatment Extension for Patients Without Rapid Virological Response

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: HepNet Study House, German Liverfoundation · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this study we intend to treat patients with chronic hepatitis C of genotype 2 or 3 having characteristics associated with poor treatment response for additional 12 or 24 weeks beyond the standard treatment of PEG-IFN alpha-2b plus ribavirin. The objective of this study is to compare the efficacy of a treatment extension of 12 versus 24 weeks in patients with HCV-genotypes 2 and 3 who are treated with 1.5 µg/kg PEG-IFN alpha-2b and 800-1400 mg ribavirin (standard dose) for 24 weeks (standard duration) and who are not HCV-RNA negative (\< 15 IU/ml) after 4 weeks of standard treatment but HCV-RNA negative after 16-24 weeks of standard treatment.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	pegylated interferon alpha-2b	1.5 µg/kg once weekly, syringe, 24 weeks
DRUG	Ribavirin	800-1400 mg per os, daily, tablets, 24 weeks
DRUG	pegylated Interferon alpha-2b	1.5 µg/kg once weekly, syringe, 12 weeks
DRUG	Ribavirin	800-1400 mg per os, daily, tablets, 12 weeks

Timeline

• Start date: 2008-11-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2008-12-05
• Last updated: 2017-08-28

Locations

49 sites across 1 country: Germany