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Individually Adapted Therapy Duration for the Treatment of Chronic Hepatitis C Genotype 1 Infection

NCT00351403 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 390

Last updated 2010-02-08

No results posted yet for this study

Summary

Patients with chronic hepatitis C genotype 1 virus infection are usually treated with Interferon alfa plus Ribavirin over 48 weeks. For some patients this might be too long, for others too short. An individually adapted therapy length from 24 to 72 weeks will be determined in dependence of the initial virus load and the time to HCV RNA negativity.

The primary objective is to compare the cumulative rate of the sustained viral response (SVR) of the patients with the individually adapted therapy duration to the SVR rates of a historic patient collective under the 48 week standard therapy.

Conditions

  • Hepatitis C, Chronic

Interventions

DRUG

Ribavirin

Rebetol 200 mg: applied as hard capsule

DRUG

Peginterferon alfa 2b

PegIntron (50/80/100/120/150 microgram): applied by injection

Sponsors & Collaborators

  • University Hospital, Saarland

    collaborator OTHER

  • FGK Clinical Research GmbH

    lead INDUSTRY

Principal Investigators

  • Christoph Sarrazin, MD, PhD · University Hospital, Saarland

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2010-01-31
Completion
2010-01-31

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 NCT00351403 on ClinicalTrials.gov