The effect of peroxisome proliferator activator receptor * agonist pre-treatment on pegylated interferon-*2a and ribavirin efficacy in hepatitis C patients, previously resistant to treatment with pegylated interferon and ribavirin - a randomized-controlled trial

Withdrawn

Conditions: Viral liver disease
Hepatitis C
10019654
10047438

Registration Number: NL-OMON31787

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

* CHC genotype 1 infected men and women * 21 and * 65 yrs of age
* Previously non-responders or relapsers to any PEG-IFN-containing treatment
* Patients requiring a liver biopsy before treatment
* Fasting plasma glucose *7.0 mmol/l
* Hepatic steatosis
* Written informed consent

Exclusion Criteria

* Exclusion criteria for MRI
* ALT levels * 150 IU/ml
* Co-infection with HIV or hepatitis B
* Present excessive alcohol use defined as > 2 units/day
* Cardiovascular co-morbidity
* 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Outcome is presented as non-detectable hepatitis C virus, 6 months after<br /><br>finishing PEG-IFN/RBV therapy.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Prior to randomisation, at 16 weeks and at 28 weeks, patients will undergo<br /><br>liver biopsies to assess disease activity and histomorphology, and 1H-MRS to<br /><br>non-invasively quantify liver fat accumulation. In addition, insulin resistance<br /><br>will be assessed by an oral glucose tolerance test (OGTT). Finally, various<br /><br>metabolic parameters and markers of inflammation and oxidative stress will be<br /><br>measured</p><br>