Ambrisentan for Treatment of Portopulmonary Hypertension

• Status: Withdrawn
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Graz
• Treatments: Ambrisentan

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