Ambrisentan for Treatment of Portopulmonary Hypertension
|ClinicalTrials.gov Identifier: NCT01733095|
Recruitment Status : Withdrawn (slow recruitment)
First Posted : November 26, 2012
Last Update Posted : June 17, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Portopulmonary Hypertension||Drug: ambrisentan||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ambrisentan for Treatment of Portopulmonary Hypertension (PoPH): a Pilot Study|
|Study Start Date :||July 2012|
|Primary Completion Date :||April 2016|
|Study Completion Date :||June 2016|
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.
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.
Other Name: Volibris
- pulmonary vascular resistance [ Time Frame: week 24 ]
- mean arterial pulmonary pressure [ Time Frame: week 24 ]
- hepatic venous pressure gradient [ Time Frame: week 24 ]
- exercise capacity [ Time Frame: week 24, 48 ]
- quality of life [ Time Frame: week 24, 48 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01733095
|Medical University of Graz|
|Graz, Austria, 8036|
|Principal Investigator:||Rudolf E. Stauber, MD||Gastroenterology & Hepatology|
|Study Director:||Horst Olschewski, MD||Pulmonology|