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Individually Adapted Therapy Duration for the Treatment of Chronic Hepatitis C Genotype 1 Infection
This study is currently recruiting participants.
Verified by FGK Clinical Research GmbH, January 2009
Sponsors and Collaborators: FGK Clinical Research GmbH
Universitätsklinikum des Saarlandes
Information provided by: FGK Clinical Research GmbH
ClinicalTrials.gov Identifier: NCT00351403
  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 IV

MedlinePlus related topics: Hepatitis Hepatitis C
Drug Information available for: Ribavirin Peginterferon Alfa-2b
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Parallel Assignment, Safety/Efficacy Study
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

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
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
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

Contacts
Contact: Christoph Sarrazin, MD. PhD +49-6841-16-23203 christoph.sarrazin@uniklinikum-saarland.de
Contact: Robert Sieglstetter, PhD +49-89-893119-37 robert.sieglstetter@fgk-cro.de

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

Study ID Numbers: INDIV-2
Study First Received: July 11, 2006
Last Updated: January 12, 2009
ClinicalTrials.gov Identifier: NCT00351403  
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)

Study placed in the following topic categories:
Interferon-alpha
Liver Diseases
Hepatitis, Chronic
Interferons
Ribavirin
Hepatitis, Viral, Human
Hepatitis
Virus Diseases
Digestive System Diseases
Peginterferon alfa-2b
Hepatitis C
Interferon Alfa-2a
Hepatitis C, Chronic
Interferon Alfa-2b

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Flaviviridae Infections
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Infection
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on January 14, 2009