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

About this trial
This is an interventional treatment trial for Hepatitis C, Chronic focused on measuring Chronic HCV infection, Genotype 1, Individually adapted therapy, Peginterferon alfa-2b, Ribavirin, Sustained viral response (SVR)
Eligibility 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.
Sites / Locations
- Medizinische Universitätsklinik Freiburg
- Universitätsklinik Heidelberg
- Universitätsklinikum Ulm
- Uniklinikum Erlangen
- Klinikum Großhadern
- Technische Universität München
- Klinikum der Universität Würzburg
- Klinikum der J.W.-Goethe-Universität
- Praxis für Innere Medizin
- Medizinische Hochschule Hannover
- St. Josef-Hospital
- Gemeinschaftspraxis
- Medizinische Universitäts-Klinik Essen
- Universität zu Köln
- Universitätsklinikum Aachen
- Universitätsklinikum der J. Gutenberg Universität
- Universitätsklinikum des Saarlandes
- Universitätsklinikum Leipzig
- Christian-Albrechts-Universität zu Kiel
- Hepatologische Schwerpunktpraxis
- Charité, Campus Virchow-Klinikum
- Universitätsklinikum Hamburg-Eppendorf
Arms of the Study
Arm 1
Arm 2
Experimental
Other
Individualized therapy
Historical control
Lengh of therapy depends on time point when no HCV RNA is detectable in blood with Versant HCV Qualitative assay.
48 week standard therapy