A prospective clinical trial examining the effects of bosentan, a drug used for vascular dysfunction, on patients with liver cirrhosis and hepatopulmonary syndrome, wich is characterized by shortness of breath and hypoxemia (low oxygen levels in the blood of the arteries) caused by vascular abnormalities in the lungs of patients with liver disease.

• Conditions: HPS is by far the most frequent respiratory complication of cirrhosis leading to significantly increased mortality. The only therapeutic option is liver transplantation. Many patients with HPS who are screened for liver transplantation are not listed for transplantation due to several reasons. Therefore, an effective medical treatment of HPS would be of central importance and may revolutionise the management in this frequent syndrome.; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2010-023366-49-AT
• Lead Sponsor: Med. Univ. Wien, Univ. Klinikum für Interne Medizin III

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-07
• Last Update Posted: 7 April 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

1.) presence of hepatopulmonary syndrome
2.) age > 18 years
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18

Exclusion Criteria

1.) intracardiac shunting

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the efficacy and safety of bosentan in patients with liver mild cirrhosis and hepatopulmonary syndrome.;Secondary Objective: To assess safety and tolerability of bosentan<br>To asses effect of bosentan treatment on quality of live<br>To assess effects of bosentan on pulmonary gas exchange and exhaled nitric oxide levels<br>To assess effects of bosentan on liver function parameters and endothelin levels and on hepatic hemodynamics<br>;Primary end point(s): Primary:<br>-Changes in 6-minute walking distance before and after 12 weeks of therapy with bosentan, respectively in patients with bosentan and the placebo group<br>-Changes in gas exchange (PaO2, AaDO2) before and after 12 weeks of therapy with bosentan, respectively in patients with bosentan and the placebo group<br><br>;Timepoint(s) of evaluation of this end point: see E.5.1