Ambrisentan for Treatment of Portopulmonary Hypertension

NCT ID: NCT01733095

Last Updated: 2016-06-17

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2016-06-30

Brief Summary

Portopulmonary hypertension denotes pulmonary hypertension complicating portal hypertension and is present in approximately 5% of cirrhotic patients. Treatment options include prostanoids, sildenafil, and the endothelin-receptor antagonists, bosentan and ambrisentan.

This study investigates the safety and efficacy of ambrisentan in portopulmonary hypertension.

Detailed Description

Patients with clinically significant PoPH (resting mean pulmonary arterial pressure >25 mm Hg, pulmonary vascular resistance >400 dynes*s*cm-5) will be offered treatment with ambrisentan. Patients will be followed clinically and hemodynamically up to 12 months after start of treatment.

Conditions

Portopulmonary Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ambrisentan

In all patients with clinically significant PoPH, ambrisentan will be administered orally using a low ascending dose regime (see below). Duration of treatment will be 12 months.

Group Type: EXPERIMENTAL

ambrisentan

Intervention Type: DRUG

Ambrisentan (Volibris 5 mg film-coated tablets, Glaxo Smith-Kline) will be started at 5 mg every other day and increased to 5 mg daily after 4 weeks if tolerated well.

Interventions

ambrisentan

Ambrisentan (Volibris 5 mg film-coated tablets, Glaxo Smith-Kline) will be started at 5 mg every other day and increased to 5 mg daily after 4 weeks if tolerated well.

Intervention Type: DRUG

Other Intervention Names

Volibris

Eligibility Criteria

Inclusion Criteria

• Adult patients with portal hypertension, age >18 years
• Cirrhosis of any etiology; Child-Pugh class A and B
• Noncirrhotic portal hypertension (e.g. chronic portal vein thrombosis)
• Informed consent

Exclusion Criteria

• Presence of other causes for pulmonary arterial hypertension
• History of pulmonary embolism or myocardial infarction within 6 months before study start
• Child-Pugh class C
• Presence of hepatocellular carcinoma
• Liver transplantation
• HIV infection
• Severe obstructive or restrictive pulmonary disease (predicted FEV1 or VC <65%, respectively)
• Severe dilated cardiomyopathy (EF <50%)
• Latent left-heart insufficiency
• Pregnancy and lactation
• Esophageal variceal hemorrhage within the last 6 months
• Refractory ascites
• Hepatorenal syndrome
• Persistent hepatic encephalopathy > grade 1
• Bilirubin >3.0 mg/dl
• AST and/or ALT >3x ULN
• Creatinine >2.0 mg/dl
• Known hypersensitivity to ambrisentan

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rudolf E. Stauber, MD

Role: PRINCIPAL_INVESTIGATOR

Gastroenterology & Hepatology

Horst Olschewski, MD

Role: STUDY_DIRECTOR

Pulmonology

Locations

Medical University of Graz

Graz, , Austria

Countries

Austria

Other Identifiers

PoPH-GRZ ambrisentan

Identifier Type: -

Identifier Source: org_study_id