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

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2005-001454-24-LT
• Date of registration: 04/05/2005
• Prospective Registration: Yes
• Primary sponsor: RIEMSER Arzneimittel AG
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 08/06/2005
• Target sample size: 45
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-001454-24
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Lithuania

Key inclusion & exclusion 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:
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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Intervention(s)

Product Name: Cis-4-Hydroxy-L-Proline
Product Code: 3108006977
Pharmaceutical Form: Oral powder

Primary Outcome(s)

Primary end point(s):

Secondary Objective: To assess the anti-fibrotic activity of CHP in patients with chronic liver disease

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 ID(s)

IPSS B025-L