E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Liver transplant candidates with alcohol induced liver cirrhosis and hypomagnesemia (P-Mg under 0,71 or magnesium substitution at least 750 mg/day) |
Maksansiirtoarviossa olevat alkoholin aiheuttamaa maksakiroosia sairastavat potilaat, joilla on magnesiumin puute (P-Mg alle 0,71 tai magnesiumsubstituutio vähintään 750 mg/vrk). |
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E.1.1.1 | Medical condition in easily understood language |
Liver transplant candidates with alcohol induced liver cirrhosis and lack of magnesium |
Maksansiirtoarviossa olevat alkoholin aiheuttamaa maksakirroosia sairastavat potilaat, joilla on magnesiumin puute |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10024667 |
E.1.2 | Term | Liver cirrhosis |
E.1.2 | System Organ Class | 100000004871 |
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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 |
To find out if by giving magnesium it would be possible to enhance blood coagulation tendencies amongst patients with alcohol induced liver cirrhosis |
Selvittää, voidaanko magnesiumia antamalla parantaa alkoholimaksakirroosia sairastavien potilaiden veren hyytymisominaisuuksia.
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E.2.2 | Secondary objectives of the trial |
Not applicable |
Not applicable |
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E.2.3 | Trial contains a sub-study | No |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Not applicable |
Not applicable |
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E.3 | Principal inclusion criteria |
Age between 18-70 years
Liver transplant candidate
Alcohol induced liver cirrhosis
Hypomagnesemia (P-Mg below 0,71 or magnesium substitution at least 750 mg/vrk) |
Tutkimukseen otetaan 20 iältään 18-70 -vuotiasta, maksansiirtoarviossa olevaa, alkoholimaksakirroosia sairastavaa potilasta, joilla on tiedossa oleva hypomagnesemia (P-Mg alle 0,71) tai per oraalinen magnesium-substituutio vähintään annoksella 750 mg/day. Mikäli potilaalla on magnesium-substituutio, se tauotetaan 2 viikkoa ennen tutkimusta.
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E.4 | Principal exclusion criteria |
Age under 18 years or over 70 years
Non alcohol induced liver cirrhosis
Normal magnesium plasma levels without magnesium substitution
Magnesium substitution under 750 mg/day |
Ikä alle 18 tai yli 70
Ei-alkoholin aiheuttama maksakirroosi
Normaali plasman magnesiumtaso ilman magnesiumsubstituutiota
Magnesiumsubstituutio alle 750 mg/vrk |
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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 | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
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 | Yes |
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) | 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 | Yes |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |