Bosentan for Treatment of Hepatopulmonary Syndrome in Patients With Liver Cirrhosis

Liver Cirrhosis Clinical Trial

Official title:

Bosentan for Treatment of Hepatopulmonary Syndrome in Patients With Liver Cirrhosis - a Prospective Double Blind Randomized Controlled Clinical Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01518595
• Other study ID #: 1-Fuhrmann
• Status: Terminated
• Phase: Phase 2
• First received: October 26, 2011
• Last updated: September 27, 2016
• Start date: October 2011

Study information

• Verified date: September 2016
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibrosis
• Hepatopulmonary Syndrome
• Liver Cirrhosis
• Syndrome

Intervention

Drug:
• bosentan
pts. will receive bosentan for 3 months
• Placebo
pts. will receive placebo for 3 months

Locations

Country	Name	City	State
Austria	Medical University Vienna, Dpt. of Internal Medicine 3, Div. of Gastroenterology and Hepatology	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	alveolar-arterial oxygen gradient in mmHg		3 months	Yes
Secondary	presence of HPS	assessment via contrast enhanced transthoracic echocardiography and pulmonary function testing	3 months	No
Secondary	6 minutes walking distance in m		3 months	No
Secondary	WHO functional class		3 months	No
Secondary	quality of life	we will us the CAT-questionaire for QoL assessment	3 months	No
Secondary	aminotransferase level (ASAT, ALAT)	Assessment of the aminotransferase levels in U/L	3 months	Yes
Secondary	exhanled nitric oxide in parts per billion		3 months	No
Secondary	hepatic venous pressure gradient (HVPG) in mmHg	HVPG will be assessed after inclusion in the study and after 3 months	3 months	No
Secondary	pulmonary hemodynamics	pulmonary hemodynamics will be assessed after inclusion and after 3 months	3 months	No
Secondary	mean arterial blood pressue in mmHg		3 months	Yes
Secondary	partial pressure of arterial oxygen in mmHg		3 months	No