Chronic hepatitis C infection MedDRA version: 9.1 Level: LLT Classification code 10008912 Term: Chronic hepatitis C
Conditions
Interventions
Trade Name: Actos
Pharmaceutical Form: Capsule*
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Trade Name: Pegasys
Pharmaceutical Form: Injection*
Prod
Sponsors
VU university medical center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? CHC genotype 1 infected men and women = 21 and = 65 yrs of age ? Previously non-responders or relapsers to PEG-IFN and RBV containing treatment ? Previous resistance to antiviral therapy will be defined as: - Decrease in PCR detected viral load of =2log in response to at least 12 weeks of treatment with PEG-IFN and RBV containing treatment - Recurrence of HCV-RNA, previously undetectable after treatment of at least 12 weeks with PEG-IFN and RBV containing treatment (breakthrough and relapse) ? Patients requiring a liver biopsy before treatment ? Fasting plasma glucose =7.0 mmol/l ? Hepatic steatosis defined as increased hyperechogenicity on abdominal ultrasound and/or histological signs of steatosis (grade 0-3 according to the NASH clinical research network scoring system) ? 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: ? Exclusion criteria for MRI (claustrophobia, pacemaker, metal implants, etc) Exclusion criteria for liver biopsy (bleeding tendency, extended bile ducts etc) ? ALT levels = 150 IU/ml ? Co-infection with HIV or hepatitis B ? Present excessive alcohol use defined as > 2 units/day ? Cardiovascular co-morbidity defined as heart failure, coronary insufficiency and hypertension in past history ? Any type of diabetes mellitus ? Use of glucocorticosteroids, hormonal substitution, pagitaxel, theofyllin, myelosuppresive agents. ? A psychiatric, addictive or any other disorder that compromises the subjects ability to understand the study content and to give written informed consent for participation in the study ? Present abuse of i.v. drugs (including methadon) ? Subject no longer available for follow-up assessment ? Standard contraindication for treatment with PEG-IFN and RBV such as: - Decompensated liver cirrhosis - Pregnancy / breastfeeding - Lack of appropriate contraception - Expected non-compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the effect of a 16-week treatment with PPAR-? agonist versus placebo on the effectiveness of subsequent standard treatment with PEG-IFN and RBV on disease activity, measured as SVR, in previously non-responding or relapsing CHC genotype 1 patients.;Secondary Objective: Secondary objectives are to study associations of disease activity, liver fat content, liver function, liver histomorphology, insulin sensitivity and response to antiviral therapy;Primary end point(s): The primary outcome measure, the responsiveness to antiviral therapy of previously non-responding and relapsing CHC patients genotype 1, is expressed as the portion of participants with SVR in the PPAR-? treated and placebo group. SVR is defined as undetectable serum HCV-RNA 6 months after completing PEG-IFN-a2a and RBV therapy. | — |
Countries
Netherlands
Outcome results
None listed