Chronic viral hepatitis, Chronic alcoholic liver diseases without cirrhosis, Compensated alcoholic liver cirrhosis, Primary Billiary Cirrhosis or Primary Sclerosing Cholangitis MedDRA version: 1.1 Level: SOC Classification code 10019805
Conditions
Interventions
Product Name: Cis-4-Hydroxy-L-Proline
Product Code: 3108006977
Pharmaceutical Form: Oral powder
Sponsors
RIEMSER Arzneimittel AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed Informed Consent 2. Female and male 3. Age 18 or over 4. Performance status: WHO 0-2 5. Confirmed diagnosis of one of the following: • Chronic viral hepatitis • Chronic alcoholic liver diseases without cirrhosis • Compensated alcoholic liver cirrhosis • Primary Billiary Cirrhosis or Primary Sclerosing Cholangitis 6. Life expectancy of at least three months 7. No prior chemotherapy or radiotherapy 8. Haematology (WBCs = 2.0x10^9/l and platelets = 50.0x10^9/l) 9. Geographical and other conditions allow adequate treatment and follow up 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: 1. Known intolerability to cis-4-hydroxy-L-proline (CHP) 2. Inability or unwillingness to give written informed consent 3. Inability or unwillingness to co-operate adequately 4. Inability to take medication orally 5. Acute intercurrent illness 6. Uncontrolled concomitant diseases (diabetes, hypertension, cardiac disorders, etc) 7. Pregnant or lactating women 8. Concomitant medication or procedures which could interfere with the study or with basic therapy or with the study medication 9. Current participation in another clinical study or participation in any other study during the 30 days before the start of this study 10. Patients with immunoimpairment - patients with Leucoses - patients with HIV - patients with any carcinoma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy, safety and quality of life following the treatment of: ? Chronic viral hepatitis ? Chronic alcoholic liver diseases without cirrhosis ? Compensated alcoholic liver cirrhosis ? Primary Billiary Cirrhosis or Primary Sclerosing Cholangitis with oral CHP;Secondary Objective: To assess the anti-fibrotic activity of CHP in patients with chronic liver disease;Primary end point(s): | — |
Countries
Lithuania
Outcome results
None listed