Study to Assess the Efficacy of 12 Versus 24 Weeks of Extended Treatment in HCV-Genotype 2/3 Patients
Status:
Terminated
Trial end date:
2013-08-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
HepNet Study House, German Liverfoundation
Collaborators:
Hannover Clinical Trial Center GmbH Hannover Medical School