E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chonical terminal liver insufficiency |
|
E.1.1.1 | Medical condition in easily understood language |
Chonical terminal liver insufficiency: is a liver disfunction in final stage |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10024714 |
E.1.2 | Term | Liver transplant |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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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 |
highest measured GPT level on the first two postoperative days |
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E.2.2 | Secondary objectives of the trial |
GPT, GOT postoperative on day 1,2,4,7
function of the graft (Quick-Test, Bilirubin)
organ- and patient survival
biopsy verified refection |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Donor:organ donor with at least two of the following marginality criteria (according to Eurotransplant manual Extnded Criteria Liver Conors, 09/03/2009):
donors age>65
macro vesicular steatosis >40%
Na> 165 mmol/l
intensive care and ventilation >7 days
BMI >30
cold ischemia time >13 hours GPT>105 U/l GOT >99 U/l
Bilirubin >3mg/dl Bilirubin (> 51 µmol/l)
giving of adrenaline
Recipient:
listing for a liver transplantation at one of the participating sites
first liver transplantation
age >18 years
signed informed consent |
|
E.4 | Principal exclusion criteria |
Donor:
at least one of the following riskfactors: active hepatitis B-or hepatitis C-infection
Recipient:
multi organ transplant
HU listing
Extra hepatic tumor disease
pregnancy
refusal or withdrawal of the patient or their relatives
institutionalization based on official order or court order
missing or lacking knowledge of german, so that the understanding of the written patient information is not guaranteed
|
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E.5 End points |
E.5.1 | Primary end point(s) |
maximum of the hepatocellular damage within the first 48 hoursof the liver transplantation. The damage will be qualified by GPT |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
postoperative day 1 and 2 |
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E.5.2 | Secondary end point(s) |
GPT, Got postoperative on day 1,2,4,7
function of the transplant(Quick-Test, Bilirubin)
Organ-and Patient survival
biopsy verified rejection |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
postoperative day 1,2,4,7 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
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 | No |
E.8.7 | Trial has a data monitoring committee | No |
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
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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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |