- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01733095
Ambrisentan for Treatment of Portopulmonary Hypertension
June 16, 2016 updated by: Medical University of Graz
Ambrisentan for Treatment of Portopulmonary Hypertension (PoPH): a Pilot Study
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.
Study Overview
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
Interventional
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Graz, Austria, 8036
- Medical University of Graz
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
pulmonary vascular resistance
Time Frame: week 24
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week 24
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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mean arterial pulmonary pressure
Time Frame: week 24
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week 24
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hepatic venous pressure gradient
Time Frame: week 24
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week 24
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exercise capacity
Time Frame: week 24, 48
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week 24, 48
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quality of life
Time Frame: week 24, 48
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week 24, 48
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rudolf E. Stauber, MD, Gastroenterology & Hepatology
- Study Director: Horst Olschewski, MD, Pulmonology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2012
Primary Completion (ACTUAL)
April 1, 2016
Study Completion (ACTUAL)
June 1, 2016
Study Registration Dates
First Submitted
November 20, 2012
First Submitted That Met QC Criteria
November 20, 2012
First Posted (ESTIMATE)
November 26, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
June 17, 2016
Last Update Submitted That Met QC Criteria
June 16, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PoPH-GRZ ambrisentan
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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