EUCTR2011-001139-22-ATActive, not recruitingPhase 1
AMBRISENTAN FOR TREATMENT OF PORTOPULMONARY HYPERTENSION (POPH): A PILOT STUDY
Medizinische Universität Graz, Klin. Abteilung für Gastroenterologie und Hepatologie0 sites12 target enrollmentStarted: May 11, 2011Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 12
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
Inclusion Criteria
- •Adult patients with portal hypertension, age >18 years
- •Cirrhosis of any etiology; Child-Pugh class A, B, or C
- •Noncirrhotic portal hypertension (e.g. chronic portal vein thrombosis)
- •Signed Informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •- Presence of other causes for PAH
- •- History of pulmonary embolism or myocardial infarction within 6 months before study start
- •-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%)
- •-Pregnancy
- •-Esophageal variceal hemorrhage within the last 6 weeks
- •-Refractory ascites
- •-Hepatorenal syndrome
- •-Persistent hepatic encephalopathy > grade 1
Investigators
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