Status:
COMPLETED
Individually Adapted Therapy Duration for the Treatment of Chronic Hepatitis C Genotype 1 Infection
Lead Sponsor:
FGK Clinical Research GmbH
Collaborating Sponsors:
University Hospital, Saarland
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief 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 i...
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 eval...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2010
Estimated Enrollment :
390 Patients enrolled
Trial Details
Trial ID
NCT00351403
Start Date
July 1 2006
End Date
January 1 2010
Last Update
February 8 2010
Active Locations (22)
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1
Medizinische Universitätsklinik Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
2
Universitätsklinik Heidelberg
Heidelberg, Baden-Wurttemberg, Germany, 69120
3
Universitätsklinikum Ulm
Ulm, Baden-Wurttemberg, Germany, 89081
4
Uniklinikum Erlangen
Erlangen, Bavaria, Germany, 91056