Influence of the selective endothelin receptor-blocker Ambrisetan on the portal pressure in patients with cirrhosis

Phase 1

Conditions: Portal hypertension and hepatic cirrhosis
MedDRA version: 16.1Level: PTClassification code 10036200Term: Portal hypertensionSystem Organ Class: 10019805 - Hepatobiliary disorders
MedDRA version: 16.1Level: LLTClassification code 10009213Term: Cirrhosis of liverSystem Organ Class: 10019805 - Hepatobiliary disorders
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2007-005679-33-DE

Lead Sponsor: Medizinische Fakultät der Martin-Luther-Universität Halle-Wittenberg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- Histologically/ laboratory or sonographically confirmed diagnosis of hepatic cirrhosis
- Compensated hepatic disease (Child A and B)
- Portal hypertension
- Age: 18 - 75
- Signed, written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24

Exclusion Criteria

- Acute infection
- Hepatic encephalopathy Stadium II- IV
- Alcoholic hepatitis and other acute manifestations of hepatitis
- Pylethrombosis
- Transaminases increased > 3 x UNL
- Advanced stadium of cardiac and/or pulmonary preventing head-down position
- Evidence of known advanced malignant disease
- Usage of beta-blockers within the last 72 hours
- Pregnancy or lactation
- Participation in another clinical trial
- Marked hypotension (systolic blood pressure less than 90 mmHg )
- Advanced hepatic disease (stadium Child C)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Efficacy of endothelin receptor-blocker on the portal pressure.<br>Normalizing of the initial increased hepatic vascular resistance or reduction of the values for 10% at minimum during therapy with endothelin-A-receptor-antagonists.;Secondary Objective: Assessment of the change of the portal pressure after application of the endothelin-receptor-blocker;Primary end point(s): Normalisazion of the initially increased portal pressure or reduction of 10% minimum compared to the initial value will be defined as binary end point with the characteristic values achieved/not achieved.;Timepoint(s) of evaluation of this end point: One day after application of study treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Reduction of endothelin-1 concentration;Timepoint(s) of evaluation of this end point: One day after application of study treatment