NCT01733095

Ambrisentan for Treatment of Portopulmonary Hypertension

Ambrisentan for Treatment of Portopulmonary Hypertension (PoPH): a Pilot Study

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Medical University of Graz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2012-07-01
• Primary completion: 2016-04-01
• Completion: 2016-06-01
• First posted: 2012-11-26
• Last updated: 2016-06-17

Locations

1 site across 1 country: Austria