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

February 5, 2010 updated by: FGK Clinical Research GmbH

Individually Adapted Therapy Duration From 24 to 72 Weeks for the Treatment of a Chronic Hepatitis C Genotype 1 Infection With Peginterferon Alfa-2b Plus Ribavirin in Dependence of the Initial Concentration and the Decline of the HCV RNA

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Further objectives of this trial are:

To record the tolerance of the therapy with Peginterferon alfa-2b plus Ribavirin over 72 weeks inclusive the adverse reactions and the withdrawal rates.

To evaluate the biochemical response to the treatment (ALT values during and after the therapy) in comparison to the virological response to the treatment.

To evaluate the validity of the withdrawal rules of this trial at week 12 and 24 in comparison to the 2-log-rule and a qualitative detection of the HCV RNA at week 24 with a detection limit of 50 IU/ml.

To evaluate the impact of the HCV RNA concentration before the therapy, and the HCV kinetic during the therapy on the response to the treatment in the different groups.

To evaluate the impact of the serum concentration of Ribavirin on anaemia and the virological therapy response, as well as the dependence of the serum concentration of Ribavirin on the creatinine clearance in comparison to the body weight.

Study Type

Interventional

Enrollment (Anticipated)

390

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 13353
        • Charité, Campus Virchow-Klinikum
      • Berlin, Germany, 10969
        • Hepatologische Schwerpunktpraxis
      • Hamburg, Germany, 20246
        • Universitätsklinikum Hamburg-Eppendorf
    • Baden-Württemberg
      • Freiburg, Baden-Württemberg, Germany, 79106
        • Medizinische Universitätsklinik Freiburg
      • Heidelberg, Baden-Württemberg, Germany, 69120
        • Universitätsklinik Heidelberg
      • Ulm, Baden-Württemberg, Germany, 89081
        • Universitatsklinikum Ulm
    • Bayern
      • Erlangen, Bayern, Germany, 91056
        • Uniklinikum Erlangen
      • München, Bayern, Germany, 81675
        • Technische Universität München
      • München, Bayern, Germany, 81377
        • Klinikum Großhadern
      • Würzburg, Bayern, Germany, 97080
        • Klinikum der Universität Würzburg
    • Hessen
      • Frankfurt, Hessen, Germany, 60590
        • Klinikum der J.W.-Goethe-Universität
      • Frankfurt, Hessen, Germany, 60596
        • Praxis für Innere Medizin
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30625
        • Medizinische Hochschule Hannover
    • Nordrhein-Westfalen
      • Bochum, Nordrhein-Westfalen, Germany, 44791
        • St. Josef-Hospital
      • Dusseldorf, Nordrhein-Westfalen, Germany, 40237
        • Gemeinschaftspraxis
      • Essen, Nordrhein-Westfalen, Germany, 45122
        • Medizinische Universitäts-Klinik Essen
      • Köln, Nordrhein-Westfalen, Germany, 50924
        • Universität zu Köln
    • Nordrhein.Westfalen
      • Aachen, Nordrhein.Westfalen, Germany, 52074
        • Universitätsklinikum Aachen
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Germany, 55131
        • Universitätsklinikum der J. Gutenberg Universität
    • Saarland
      • Homburg / Saar, Saarland, Germany, 66421
        • Universitätsklinikum des Saarlandes
    • Sachsen
      • Leipzig, Sachsen, Germany, 04103
        • Universitatsklinikum Leipzig
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Christian-Albrechts-Universität zu Kiel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with a chronic HCV infection (HCV antibodies and HCV RNA positive)
  • Presence of a HCV genotype 1 infection
  • Presence of a compensated liver disease satisfying following hematological and biochemical minimum criteria: - Hemoglobin value >= 13 g/dl in men, >= 12 g/dl in women - Leukocytes >= 3.000/mm3 or neutrophile granulocytes > 1.500/mm3 - Thrombocytes > 80.000/mm3
  • Total bilirubin in the normal range
  • Albumin in the normal range
  • Serum creatinine in the normal range THS in the normal range
  • Exclusion of an autoimmune hepatitis
  • Alpha-Fetoprotein in the normal range
  • Negative HIV test
  • Negativity of Hepatitis B surface antigens (Hbs-Ag)
  • Normal or elevated ALT/GTP values at screening
  • At known diabetes mellitus or hypertension an ophthalmologic examination must be performed
  • Liver biopsy within the last 12 months must confirm the diagnoses of a chronic hepatitis
  • A confirmation must be given that sexually active patients practice a save method of contraception during the therapy and 6 (women) to 7 (men) months after the therapy

Exclusion Criteria:

  • Age < 18 years, > 70 years
  • Previous treatment of hepatitis c with (Peg)Interferon alfa or (Peg)Interferon alfa/Ribavirin
  • Patients with organ transplantations other than cornea or hair
  • Infection with HCV genotype 2,3,4,5 or 6
  • Pregnant or nursing women
  • Any other reason for the liver disease than chronic hepatitis C
  • Suspected hypersensitivity to Interferon, Peginterferon or Ribavirin
  • Participation in a clinical trial or treatment with an investigational product 30 days before inclusion in this study
  • Patients with any kind of hemoglobinopathy
  • Documented liver disease in advanced state Liver cirrhosis Child B and C
  • Each known and existing clinical conditions that might challenge the participation or completion of this clinical trial as depressions, psychosis, severe psychiatric diseases, suicide ideations CNS traumata or cramps which need medicamentous treatment
  • Relevant cardiovascular dysfunctions in the last 6 months or patients with clinically relevant changes in the ECG
  • Insufficiently adjusted diabetes mellitus
  • Severe chronic lung diseases (as e.g. COPD)
  • Immunologic diseases or autoimmune-diseases or any other disease which demand a longtime treatment with corticosteroids during this clinical trial
  • Clinically relevant gout
  • Abuse of drugs, alcohol or pharmaceuticals
  • Patient with clinically relevant changes of the retina
  • Missing ability or willingness to understand the purpose of this study or to give a written consent for participating in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Individualized therapy
Lengh of therapy depends on time point when no HCV RNA is detectable in blood with Versant HCV Qualitative assay.
Drug: Ribavirin
Rebetol 200 mg: applied as hard capsule
Drug: Peginterferon alfa 2b
PegIntron (50/80/100/120/150 microgram): applied by injection
Other: Historical control
48 week standard therapy
Drug: Ribavirin
Rebetol 200 mg: applied as hard capsule
Drug: Peginterferon alfa 2b
PegIntron (50/80/100/120/150 microgram): applied by injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Sustained viral response (HCV RNA negativity 24 weeks after end of treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

FGK Clinical Research GmbH

Collaborators

University Hospital, Saarland

Investigators

  • Study Chair: Christoph Sarrazin, MD, PhD, University Hospital, Saarland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

July 11, 2006

First Submitted That Met QC Criteria

July 11, 2006

First Posted (Estimate)

July 12, 2006

Study Record Updates

Last Update Posted (Estimate)

February 8, 2010

Last Update Submitted That Met QC Criteria

February 5, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INDIV-2
  • 2006-000358-38 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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