Clinical, morphological and biochemical effects of antioxidant treatment of patients with chronic hepatitis C.
- Conditions
- Chronic hepatitis C with moderate to severe liver damage.The patients should not be suitable for standard medical treatment or refuse standard medical treatment for personal reasons.
- Registration Number
- EUCTR2005-002455-41-SE
- Lead Sponsor
- Karolinska Institutet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Chronic hepatitis C with high activity and liver damage (fibrosis stage >2, inflammation grade >2 and persistant increase in transaminases, ALAT >2). The patient should be non-responders to conventional therapy or reject therapy. Age > 20 years old.
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
Responders to conventional therapy. Low activity and mild liverdamage (fibrosis stage <2, inflammation grade <2), ongoing alcohol abuse, BMI >30, Pregnancy and lactation.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the effects of SelenoPrecise and Coenzyme Q10 on clinical and biochemical signs of disease activity and morfological signs of inflammatory activity and fibrosis in the livers.;Secondary Objective: To compare SelenoPrecise with SelenoPrecise and Coenzyme Q10 together.;Primary end point(s): Decreased inflammatory activity (> 1 grade), decrease in transaminases (>30%) and <br>decrease in fibrosis (>0.5 stage).
- Secondary Outcome Measures
Name Time Method