Ambrisentan for Treatment of Portopulmonary Hypertension
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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Recruitment Status : Withdrawn (slow recruitment)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|
|Actual Primary Completion Date :||April 2016|
|Actual 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|