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

NCT00803309 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2017-08-28

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Hannover Medical School

    collaborator OTHER

  • HepNet Study House, German Liverfoundation

    lead NETWORK

Principal Investigators

  • Michael P. Manns, Prof. Dr. · Hannover Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00803309 on ClinicalTrials.gov