An Open Labelled, Clinical Phase II Study With Oral Cis-U-Hydroxy-L-Proline (CHP) in 45 Patients With:- Chronic viral hepatitis- Chronic alcoholic liver diseases without cirrhosis- Compensated alcoholic liver cirrhosis- Primary Billiary Cirrhosis or Primary Sclerosing Cholangitis - B025-L CHP Chronic liver disease

Active, not recruiting

• Conditions: Chronic viral hepatitis, Chronic alcoholic liver diseases without cirrhosis, Compensated alcoholic liver cirrhosis, Primary Billiary Cirrhosis or Primary Sclerosing Cholangitis; MedDRA version: 1.1Level: SOCClassification code 10019805

• Registration Number: EUCTR2005-001454-24-LT
• Lead Sponsor: RIEMSER Arzneimittel AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05-04
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 45

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

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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy, safety and quality of life following the treatment of:<br><br>?Chronic viral hepatitis<br>?Chronic alcoholic liver diseases without cirrhosis <br>?Compensated alcoholic liver cirrhosis<br>?Primary Billiary Cirrhosis or Primary Sclerosing Cholangitis<br> <br> with oral CHP;Secondary Objective: To assess the anti-fibrotic activity of CHP in patients with chronic liver disease;Primary end point(s):