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.
Conditions
Interventions
Trade Name: SelenoPrecise
Product Name: SelenoPrecise
Pharmaceutical Form: Tablet
INN or Proposed INN: selen som selenjäst, selenometionin
Concentration unit: µg microgram(s)
Concentration type: equal
Sponsors
Karolinska Institutet
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: Responders to conventional therapy. Low activity and mild liverdamage (fibrosis stage 30, Pregnancy and lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 decrease in fibrosis (>0.5 stage). | — |
Countries
Sweden
Outcome results
None listed