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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-005679-33-DE

Enrollment

Unknown

Registered

2010-10-04

Start date

2011-01-20

Completion date

Unknown

Last updated

2017-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Portal hypertension and hepatic cirrhosis MedDRA version: 16.1 Level: PT Classification code 10036200 Term: Portal hypertension System Organ Class: 10019805 - Hepatobiliary disorders MedDRA version: 16.1 Level: LLT Classification code 10009213 Term: Cirrhosis of liver System Organ Class: 10019805 - Hepatobiliary disorders

Interventions

Trade Name: Volibris 10 mg Pharmaceutical Form: Coated tablet INN or Proposed INN: AMBRISENTAN CAS Number: 0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10-

Eligibility

Sex/Gender

All

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
Main Objective: Efficacy of endothelin receptor-blocker on the portal pressure. 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	—

Measure

Time frame

Main Objective: Efficacy of endothelin receptor-blocker on the portal pressure. 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

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

Countries

Germany

Contacts

Public ContactKlinik für Innere Medizin I

Universitätsklinikum Halle

alexander.zipprich@uk-halle.de+493455572665

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026