The effect of peroxisome proliferator activator receptor ? agonist pre-treatment on pegylated interferon-a2a and ribavirin efficacy in hepatitis C patients, previously resistant to treatment with pegylated interferon and ribavirin - a randomized-controlled trial - - HEPAR study

• Conditions: Chronic hepatitis C infection; MedDRA version: 9.1Level: LLTClassification code 10008912Term: Chronic hepatitis C

• Registration Number: EUCTR2007-007075-16-NL
• Lead Sponsor: VU university medical center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

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 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified