Ambrisentan for Treatment of Portopulmonary Hypertension

Sponsor
Medical University of Graz (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01733095
Collaborator
(none)
0
1
1
47
0

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Detailed Description

Patients with clinically significant PoPH (resting mean pulmonary arterial pressure >25 mm Hg, pulmonary vascular resistance >400 dynesscm-5) will be offered treatment with ambrisentan. Patients will be followed clinically and hemodynamically up to 12 months after start of treatment.

Study Design

Study Type:
Interventional
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 :
Jul 1, 2012
Actual Primary Completion Date :
Apr 1, 2016
Actual Study Completion Date :
Jun 1, 2016

Arms and Interventions

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.

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 Names:
  • Volibris
  • Outcome Measures

    Primary Outcome Measures

    1. pulmonary vascular resistance [week 24]

    Secondary Outcome Measures

    1. mean arterial pulmonary pressure [week 24]

    2. hepatic venous pressure gradient [week 24]

    3. exercise capacity [week 24, 48]

    4. quality of life [week 24, 48]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical University of Graz Graz Austria 8036

    Sponsors and Collaborators

    • Medical University of Graz

    Investigators

    • Principal Investigator: Rudolf E. Stauber, MD, Gastroenterology & Hepatology
    • Study Director: Horst Olschewski, MD, Pulmonology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Medical University of Graz
    ClinicalTrials.gov Identifier:
    NCT01733095
    Other Study ID Numbers:
    • PoPH-GRZ ambrisentan
    First Posted:
    Nov 26, 2012
    Last Update Posted:
    Jun 17, 2016
    Last Verified:
    Jun 1, 2016
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 17, 2016