Clinical study of cerebral function in chronic hepatitis C virus patients treated with pegylated interferon alpha-2a and ribivirin - SKS-0078
- Conditions
- HCVMedDRA version: 9.1Level: LLTClassification code 10008912Term: Chronic hepatitis C
- Registration Number
- EUCTR2007-005707-18-DK
- Lead Sponsor
- Department of Infectious Diseases, Aarhus university Hospital, Skejby
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
anti-HCV and measurable HCV RNS
Genotype 1, 2 and 3
Age 18-59 years
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) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
anti-HCV treatment experienced patients
HIV
HBV (+HBsAg)
Liver cirrhosis (metavir score > 3)
Pregnancy
Alcohol and/or drug abuse
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess cerebral function in chronic hepatitis C virus patients before and after therapy with pegylated interferon alpha and ribivirin. <br><br><br>;Secondary Objective: To measure changes in HCV RNA viral load and sequences, in addition to cytokin levels following therapy<br>;Primary end point(s): Cognitive function and other neuro-psychological aspects<br>MR detectable micro-structural lesions<br>
- Secondary Outcome Measures
Name Time Method