Treatment of portopulmonary hypertension (high blood pressure in the pulmonary circulation) with ambrisentan (a medicinal product for the therapy of portopulmonary hypertension).

AMBRISENTAN FOR TREATMENT OF PORTOPULMONARY HYPERTENSION (POPH): A PILOT STUDY

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-001139-22-AT

Enrollment

Registered

2011-05-11

Start date

2011-06-29

Completion date

Unknown

Last updated

2020-03-11

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

Conditions

Portopulmonary Hypertension (PoPH) and Hepatopulmonary Syndrome HPS are present in a considerable number of patients with compensated cirrhosis. Treatment of PoPH with ambrisentan is well tolerated and improves hemodynamics as well as symptoms and physical capacity. MedDRA version: 14.0 Level: PT Classification code 10067281 Term: Portopulmonary hypertension System Organ Class: 10038738 - Respiratory, thoracic and

Interventions

Trade Name: Volibris 5 mg Filmtabletten Product Name: Ambrisentan Pharmaceutical Form: Film-coated tablet INN or Proposed INN: AMBRISENTAN

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult patients with portal hypertension, age >18 years Cirrhosis of any etiology; Child-Pugh class A, B, or C Noncirrhotic portal hypertension (e.g. chronic portal vein thrombosis) Signed 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Presence of other causes for PAH - History of pulmonary embolism or myocardial infarction within 6 months before study start -Presence of hepatocellular carcinoma -Liver transplantation -HIV infection -Severe obstructive or restrictive pulmonary disease (predicted FEV1 or VC grade 1

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the prevalence of PoPH and HPS in patients with portal hypertension seen in a referral center, using sensitive screening tools.; Secondary Objective: 2. To relate PoPH with gender, etiology of cirrhosis, and the degree of liver dysfunction as estimated by the Child-Pugh score or the model for end-stage liver disease (MELD) 3. To relate PVR with portal hemodynamic parameters and circulating vasoactive mediators such as ADMA 4. To evaluate the efficacy and safety of treatment with the endothelin receptor antagonist ambrisentan in patients with clinically significant PoPH ; Primary end point(s): Resting Pulmonary Vascular Resistance (PVR) ;Timepoint(s) of evaluation of this end point: At baseline and 6 months after the start of treatment	—

Measure

Time frame

Main Objective: To assess the prevalence of PoPH and HPS in patients with portal hypertension seen in a referral center, using sensitive screening tools.; Secondary Objective: 2. To relate PoPH with gender, etiology of cirrhosis, and the degree of liver dysfunction as estimated by the Child-Pugh score or the model for end-stage liver disease (MELD) 3. To relate PVR with portal hemodynamic parameters and circulating vasoactive mediators such as ADMA 4. To evaluate the efficacy and safety of treatment with the endothelin receptor antagonist ambrisentan in patients with clinically significant PoPH ; Primary end point(s): Resting Pulmonary Vascular Resistance (PVR) ;Timepoint(s) of evaluation of this end point: At baseline and 6 months after the start of treatment

—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: At baseline, 6 and 12 months after the start of treatment, respectively. For details please refer to the protocoll.;Secondary end point(s): Secondary endpoints include mPAP, HVPG, 6-min walk distance, peak VO2, VAS, SF-36, CAMPHOR score, safety (including detailed liver function tests)	—

Countries

Austria

Contacts

Public ContactMedical University of Graz, Departm

Medizinische Universität Graz, Klin. Abteilung für Gastroenterologie und Hepatologie

430316385 12731

Outcome results

None listed

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