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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Recruitment Status : Withdrawn (slow recruitment)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
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz

Tracking Information
First Submitted Date  ICMJE November 20, 2012
First Posted Date  ICMJE November 26, 2012
Last Update Posted Date June 17, 2016
Study Start Date  ICMJE July 2012
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2012)
pulmonary vascular resistance [ Time Frame: week 24 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2012)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ambrisentan for Treatment of Portopulmonary Hypertension
Official Title  ICMJE Ambrisentan for Treatment of Portopulmonary Hypertension (PoPH): a Pilot Study
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.

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Portopulmonary Hypertension
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Drug: ambrisentan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: June 16, 2016)
0
Original Estimated Enrollment  ICMJE
 (submitted: November 20, 2012)
10
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01733095
Other Study ID Numbers  ICMJE PoPH-GRZ ambrisentan
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medical University of Graz
Study Sponsor  ICMJE Medical University of Graz
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rudolf E. Stauber, MD Gastroenterology & Hepatology
Study Director: Horst Olschewski, MD Pulmonology
PRS Account Medical University of Graz
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP