Ambrisentan for Treatment of Portopulmonary Hypertension
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ClinicalTrials.gov Identifier: NCT01733095 |
Recruitment Status :
Withdrawn
(slow recruitment)
First Posted : November 26, 2012
Last Update Posted : June 17, 2016
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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 |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: 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.
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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.
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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Austria | |
Medical University of Graz | |
Graz, Austria, 8036 |
Principal Investigator: | Rudolf E. Stauber, MD | Gastroenterology & Hepatology | |
Study Director: | Horst Olschewski, MD | Pulmonology |
Responsible Party: | Medical University of Graz |
ClinicalTrials.gov Identifier: | NCT01733095 |
Other Study ID Numbers: |
PoPH-GRZ ambrisentan |
First Posted: | November 26, 2012 Key Record Dates |
Last Update Posted: | June 17, 2016 |
Last Verified: | June 2016 |
Hypertension Vascular Diseases Cardiovascular Diseases Ambrisentan Antihypertensive Agents |