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

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: FGK Clinical Research GmbH
• Collaborator: University Hospital, Saarland
• Treatments: Interferon-alpha; Peginterferon alfa-2b; Ribavirin

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.