E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] |
MedDRA Classification |
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 find if and to what extent albumin is sequestered from the blood stream during and after liver transplantation |
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E.2.2 | Secondary objectives of the trial |
To explore the recovery of liver protein synthesis after liver transplantation |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Patients undergoing liver transplantation
• Males and females ≥ 40 years
• Written informed consent
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E.4 | Principal exclusion criteria |
• Allergy to the investigational medical product
• Pregnancy or breast feeding patients
• Participation in other studies involving radiation or the use of stable isotopes within 30 days
• Bleeding > 5000 mL
• Re-transplantation, graft size reduction, or split liver
• Continuous renal replacement therapy
• Other circumstance that makes the investigator judge patient participation unsuitable.
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E.5 End points |
E.5.1 | Primary end point(s) |
Cumulative perioperative albumin shift assessed by albumin mass balance |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Measurements will begin in connection with start of anesthesia (baseline). The primary endpoint is assessed at the end of the surgical procedure (liver transplantation) and 48-72 hours later |
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E.5.2 | Secondary end point(s) |
Albumin synthesis rate (fractional and absolute), fibrinogen synthesis rate (fractional and absolute), plasma albumin, plasma volume, transcapillary escape rate of albumin |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
plasma albumin: from start of anesthesia until 72 hours after end of surgery.
all other secondary endpoints during 48-72 hours after end of surgery. |
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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 | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
This is an exploratory study of human physiology in connection with liver transplantation.
Tracer studies have no medical effects, but are used for studying human physiology. In this case, the IMP is used to measure plasma volume that is necessary to calculate the absolute synthesis rates of albumin and fibrinogen. It will also be used to assess the degree of capillary leakage which is believed to be a major contributor to the sequestration of albumin from the blood stream. |
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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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
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 | 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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The study is completed when we have collected data from 10 evaluable patients. |
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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 | 1 |
E.8.9.1 | In the Member State concerned days | |