E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
patients with decompensated liver cirrhosis and refractery ascites indicated for large /more then 5 L/ volume paracentesis |
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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 |
In our project we plan to perform randomized controlled study comparing 2 different doses of albumin (5g ang 10g per liter of fluid removed) in patietns with refractory ascites after large volume paracentesis. The trial should answer according to actual guidelines (2009) unresolved questions, regarding efficacy of various doses of albumin, cost-effectivness of albumin administration and survival a the specific study endpoint. |
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E.2.2 | Secondary objectives of the trial |
In our study we will perform echocardiographic assessment and we will bring direct hemodynamic changes after large paracentesis followed by various albumin substitution. Last but not least, we gain knowledge about BNP levels during these changes. Another endpoint will be time to readmission to the hospital during follow-up. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Subject is 18 years of age or older male or non-pregnant female • Decompensate liver cirrhosis with refractory ascites and indication for paracetesis more then 5 L. • Informed consent in accordance with Act 129/2003 Sb., §34, sect. 8 or 3d and GCP E6, sect. 4.8.15
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E.4 | Principal exclusion criteria |
• Woman who are pregnant or lactating • Known or suspected hypersensitivity to albumin • Acute coronary artery disease • Pulmonary oedema, decompensation of heart failure • Documented sustained severe hypertension (systolic blood pressure >200mmHg or diastolic blood pressure >110mmHg) at enrollment • Subject has been previously enrolled in this study • Renal and postrenal anuria • Bleeding form esophageal varices in last six month • Severe anemia (Hb <80g/L) • Hemorrhagic diathesis • Known active malignancy or other serious medical comorbidity such that the subject's life expectancy is <12 month • Patients with ongoing significant active alcohol abuse will not be enrolled • Subject is part of the staff personnel directly involved with this study, or is a family member of the investigational staff
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E.5 End points |
E.5.1 | Primary end point(s) |
• survival • renal functions • Child, MELD score • albumin level • blood preasure, heart rate, vasopressor/s/ need • cardiac output/index, BNP level
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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 | 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 | Yes |
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) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
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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 | 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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significant benefit in one study branch - interim analysis |
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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 | 6 |
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 |