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Ambrisentan for Treatment of Portopulmonary Hypertension

This study is currently recruiting participants.
Verified November 2012 by Medical University of Graz
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01733095
First received: November 20, 2012
Last updated: NA
Last verified: November 2012
History: No changes posted
  Purpose

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 Intervention Phase
Portopulmonary Hypertension
 Drug: ambrisentan
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ambrisentan for Treatment of Portopulmonary Hypertension (PoPH): a Pilot Study

Resource links provided by NLM:

Drug Information available for: Ambrisentan
U.S. FDA Resources

Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • pulmonary vascular resistance [ Time Frame: week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • mean arterial pulmonary pressure [ Time Frame: week 24 ] [ Designated as safety issue: No ]
  • hepatic venous pressure gradient [ Time Frame: week 24 ] [ Designated as safety issue: No ]
  • exercise capacity [ Time Frame: week 24, 48 ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: week 24, 48 ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: July 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01733095

Locations
Austria
Medical University of Graz Recruiting
Graz, Austria, 8036
Contact: Rudolf Stauber, MD     +43-316-385-80268     rudolf.stauber@medunigraz.at    
Contact: Horst Olschewski, MD     +43-316-385-13305     horst.olschewski@medunigraz.at    
Principal Investigator: Rudolf Stauber, MD            
Sponsors and Collaborators
Medical University of Graz
Investigators
Principal Investigator: Rudolf E. Stauber, MD Gastroenterology & Hepatology
Study Director: Horst Olschewski, MD Pulmonology
  More Information

No publications provided

Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT01733095     History of Changes
Other Study ID Numbers: PoPH-GRZ ambrisentan
Study First Received: November 20, 2012
Last Updated: November 20, 2012
Health Authority: Austria: Federal Office for Safety in Health Care

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013