First time treatment in chronic hepatitis C-infection patients with elevated GGT-level without coinfections as HBV, HDV and HIV
Conditions
Interventions
Trade Name: Cedur retard
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Bezafibrat
CAS Number: 41859-67-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration numb
Sponsors
Charité Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Chronic hepatitis C - age 18-70 - anti-hepatitis C virus positive, hepatitis C virus-RNA > 1000 IU/ml - hepatitis C virus-genotype 1 - alanine aminotransferase > 1.0 x ULN - gamma-GT > 1.0 x ULN - liver biopsie within the last 12 months prior to study begin - negative urin pregnancy test for women with child bearing potential within 24 hours prior to the first intake of dosis medication - during the intake of the standard medication and during the 24 weeks after finishing medication two accepted methods of contraception have to be applied, one of them with barrier effect for man (e.g. condom) - written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - hypersensitivity to standard therapy, alfa-interferon, bezafibrat or a component of one of the medications - Pregnant or nursing women; women with child bearing potential who do not use contraceptive - Hepatitis C virus-genotype 2-6 - alcohol abuse > 20 g/d for woman and > 30g/d for men - diabetes mellitus - BMI >30 - decompensated liver cirrhosis - alfafetoproteine > 50 µg/l - platelets 1.5 mg/dl during screening, renal insufficiency (creatinine > 1.0 mg/dl) - therapy with with HMG-CoA reductase inhibitors - any other study medication within the last 6 weeks before intake of the first study medication - case history or indication of non hepatitis C associated chronic liver disease - haemoglobin 5 x ULN - lacking willingness or inability to give written informed consent, lacking data security consent, and lacking willingness for taking part in the study - persons who are detained officially or legally to an official institute
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is to compare the antiviral efficiency of a treatment consisting of bezafibrat 400 mg/d for 16 weeks followed by the standard therapy (peginterferon-alfa-2a 180 µg/week and ribavirin 1000-1200 mg/d) plus bezafibrat 400 mg/d for 12 weeks with the antiviral efficiency of a treatment consisting of placebo for 16 weeks followed by the standard therapy (see above) plus placebo for 12 weeks.;Secondary Objective: Efficiency of the pretreatment with bezafibrat, defined as reduction of gamma-GT, transaminases, alkaline phosphatase, hepatitis C virus-RNA-concentration, cholesterol, triglyceride, and glucose and the relevance of prognostic parameters particularly gamma-GT for therapy response.;Primary end point(s): Sustained virological response | — |
Countries
Germany
Outcome results
None listed