Bosentan for Treatment of Hepatopulmonary Syndrome in Patients With Liver Cirrhosis

• Sponsor: Medical University of Vienna (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01518595
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arms: 2

Study Details

Study Description

Brief Summary

The most common observed cause of gas exchange abnormalities and hypoxemia in cirrhosis is the hepatopulmonary syndrome (HPS) with a reported prevalence of 20-47% in patients with hepatic impairment and cirrhosis. HPS is by far the most frequent respiratory complication of cirrhosis. It is a progressive disease leading to significantly increased mortality. Up to date, the only therapeutic option is liver transplantation. The study hypothesis is that administration of bosentan in patients with liver cirrhosis suffering from hepatopulmonary syndrome improves gas exchange. 18 patients with liver cirrhosis fulfilling criteria of HPS according to the ERS task force criteria will be included in this block randomized, double-blind, placebo controlled study (12 patients will be treated with bosentan, 6 with placebo). Patients will receive bosentan 62,5mg b.i.d. for 4 weeks and 125 mg b.i.d. for 8 weeks or placebo. The duration of the treatment phase of the study is 12 weeks. The primary endpoint is the alteration of gas exchange after 3 months of therapy. The expected duration of the study is 2 years.

Condition or Disease	Intervention/Treatment	Phase
Hepatopulmonary Syndrome; Liver Cirrhosis	Drug: bosentan; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Bosentan for Treatment of Hepatopulmonary Syndrome in Patients With Liver Cirrhosis - a Prospective Double Blind Randomized Controlled Clinical Study
• Study Start Date: Oct 1, 2011
• Actual Primary Completion Date: Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: placebo Patients will receive placebo tablets twice daily for 3 months.	Drug: Placebo; pts. will receive placebo for 3 months
Active Comparator: bosentan pts. will receive bosentan for 3 months	Drug: bosentan; pts. will receive bosentan for 3 months

Outcome Measures

Primary Outcome Measures

1. alveolar-arterial oxygen gradient in mmHg [3 months]

Secondary Outcome Measures

1. presence of HPS [3 months]

   assessment via contrast enhanced transthoracic echocardiography and pulmonary function testing

2. 6 minutes walking distance in m [3 months]

3. WHO functional class [3 months]

4. quality of life [3 months]

   we will us the CAT-questionaire for QoL assessment

5. aminotransferase level (ASAT, ALAT) [3 months]

   Assessment of the aminotransferase levels in U/L

6. exhanled nitric oxide in parts per billion [3 months]

7. hepatic venous pressure gradient (HVPG) in mmHg [3 months]

   HVPG will be assessed after inclusion in the study and after 3 months

8. pulmonary hemodynamics [3 months]

   pulmonary hemodynamics will be assessed after inclusion and after 3 months

9. mean arterial blood pressue in mmHg [3 months]

10. partial pressure of arterial oxygen in mmHg [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Presence of HPS

• Age ≥ 18 years

Exclusion Criteria:

• Intracardiac shunting

• Pregnancy

• Known hypersensitivity to bosentan

• Use of glyburide

• Use of cyclosporin A

• Elevation of aminotransferase level of > 3 times the upper limit of normal

• Use of rifampicin

• Females of childbearing potential without use of adequate contraception

• Systolic blood pressure < 85 mmHg

• Clinical relevant anemia

• HIV-infection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University Vienna, Dpt. of Internal Medicine 3, Div. of Gastroenterology and Hepatology	Vienna		Austria	1090

Sponsors and Collaborators

• Medical University of Vienna

Investigators

• Principal Investigator: Valentin H Fuhrmann, MD, Medical University Vienna

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Valentin Fuhrmann, MD, Associate Professor of Medicine, Medical University of Vienna
• ClinicalTrials.gov Identifier: NCT01518595
• Other Study ID Numbers: 1-Fuhrmann
• First Posted: Jan 26, 2012
• Last Update Posted: Sep 28, 2016
• Last Verified: Sep 1, 2016

• Keywords provided by Valentin Fuhrmann, MD, Associate Professor of Medicine, Medical University of Vienna: patients
• Additional relevant MeSH terms: Liver Cirrhosis; Hepatopulmonary Syndrome; Syndrome; Fibrosis; Bosentan

Study Results

No Results Posted as of Sep 28, 2016