E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
In the prevention of variceal bleeding betablockers are used. The efficacy of betablockers is evaluated by repeated HVPG measurement. The aims: To evaluate the relationship between the polymorphisms of beta-2 adrenergic receptors to the treatment response in patients with portal hypertension treated with carvedilol. Project will be performed as a prospective study on 100 patients with liver cirrhosis and portal hypertension |
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E.1.1.1 | Medical condition in easily understood language |
Project will be performed as a prospective study on 100 patients with liver cirrhosis and portal hypertension. The aim is to find a relationship between non-invasive parameters and treatment response. |
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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 | 13.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10009210 |
E.1.2 | Term | Cirrhosis biliary |
E.1.2 | System Organ Class | 10019805 - Hepatobiliary disorders |
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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 evaluate the relationship between the polymorphisms of beta-2 adrenergic receptors to the treatment response in patients with portal hypertension treated with carvedilol |
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E.2.2 | Secondary objectives of the trial |
To evaluate the relationship between noninvasive parameters of hepatic fibrosis and degree of portal hypertension and to evaluate the possibility to replace the invasive measurement of HVPG by use of these parameters |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Liver cirrhosis with portal hypertension and esophageal varices
Indication for treatment with betablockers in the prevention of variceal bleeding |
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E.4 | Principal exclusion criteria |
Hepatocellular carcinoma
Advanced liver failure (Child-Pugh more than 13 points)
Contraindication to carvedilol:
Decompensated hearth failureNYHA IV
Known sensitivity to carvedilol or vehicules
Astma bronchiale
A-V block 2-3. degree
Severe bradycardie (under 50 beats/min)
Cardiogenic shock
Sick-sinus syndrom
Severe hypotension (systolic BP under 85 mm Hg)
Portosystemic shunt
Portal vein thrombosis
Gravidity or lactation
Age under 18 years |
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
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) | 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 last visit as given in protocol |
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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 | 4 |
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 | 4 |
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 |