E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic viral hepatitis, Chronic alcoholic liver diseases without cirrhosis, Compensated alcoholic liver cirrhosis, Primary Billiary Cirrhosis or Primary Sclerosing Cholangitis
|
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 1.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10019805 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
|
E.2.2 | Secondary objectives of the trial |
To assess the anti-fibrotic activity of CHP in patients with chronic liver disease |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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 |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) | |
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 3 |