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Bosentan for Treatment of Hepatopulmonary Syndrome in Patients With Liver Cirrhosis

This study has been terminated.
(too slow patient recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01518595
First Posted: January 26, 2012
Last Update Posted: September 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Valentin Fuhrmann, Medical University of Vienna
  Purpose
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 Intervention Phase
Hepatopulmonary Syndrome Liver Cirrhosis Drug: bosentan Drug: Placebo Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Valentin Fuhrmann, Medical University of Vienna:

Primary Outcome Measures:
  • alveolar-arterial oxygen gradient in mmHg [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • presence of HPS [ Time Frame: 3 months ]
    assessment via contrast enhanced transthoracic echocardiography and pulmonary function testing

  • 6 minutes walking distance in m [ Time Frame: 3 months ]
  • WHO functional class [ Time Frame: 3 months ]
  • quality of life [ Time Frame: 3 months ]
    we will us the CAT-questionaire for QoL assessment

  • aminotransferase level (ASAT, ALAT) [ Time Frame: 3 months ]
    Assessment of the aminotransferase levels in U/L

  • exhanled nitric oxide in parts per billion [ Time Frame: 3 months ]
  • hepatic venous pressure gradient (HVPG) in mmHg [ Time Frame: 3 months ]
    HVPG will be assessed after inclusion in the study and after 3 months

  • pulmonary hemodynamics [ Time Frame: 3 months ]
    pulmonary hemodynamics will be assessed after inclusion and after 3 months

  • mean arterial blood pressue in mmHg [ Time Frame: 3 months ]
  • partial pressure of arterial oxygen in mmHg [ Time Frame: 3 months ]

Enrollment: 6
Study Start Date: October 2011
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01518595


Locations
Austria
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
  More Information

Responsible Party: Valentin Fuhrmann, MD, Associate Professor of Medicine, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01518595     History of Changes
Other Study ID Numbers: 1-Fuhrmann
First Submitted: October 26, 2011
First Posted: January 26, 2012
Last Update Posted: September 28, 2016
Last Verified: September 2016

Keywords provided by Valentin Fuhrmann, Medical University of Vienna:
patients

Additional relevant MeSH terms:
Syndrome
Fibrosis
Liver Cirrhosis
Hepatopulmonary Syndrome
Disease
Pathologic Processes
Liver Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Bosentan
Antihypertensive Agents
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action