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

This study has been completed.
Sponsor:
Collaborator:
Universitätsklinikum des Saarlandes
Information provided by:
FGK Clinical Research GmbH
ClinicalTrials.gov Identifier:
NCT00351403
First received: July 11, 2006
Last updated: February 5, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Hepatitis C, Chronic
Drug: Ribavirin
Drug: Peginterferon alfa 2b
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by FGK Clinical Research GmbH:

Primary Outcome Measures:
  • Sustained viral response (HCV RNA negativity 24 weeks after end of treatment)

Estimated Enrollment: 390
Study Start Date: July 2006
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00351403

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

No publications provided by FGK Clinical Research GmbH

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christoph Sarrazin, MD, PhD, Universitätsklinikum des Saarlandes
ClinicalTrials.gov Identifier: NCT00351403     History of Changes
Other Study ID Numbers: INDIV-2, 2006-000358-38
Study First Received: July 11, 2006
Last Updated: February 5, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by FGK Clinical Research GmbH:
Chronic HCV infection
Genotype 1
Individually adapted therapy
Peginterferon alfa-2b
Ribavirin
Sustained viral response (SVR)

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Peginterferon alfa-2b
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 16, 2014