Bosentan for Treatment of Hepatopulmonary Syndrome in Patients With Liver Cirrhosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Medical University of Vienna.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Valentin Fuhrmann, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01518595
First received: October 26, 2011
Last updated: January 31, 2012
Last verified: January 2012

October 26, 2011
January 31, 2012
October 2011
October 2013   (final data collection date for primary outcome measure)
alveolar-arterial oxygen gradient in mmHg [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01518595 on ClinicalTrials.gov Archive Site
  • presence of HPS [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    assessment via contrast enhanced transthoracic echocardiography and pulmonary function testing
  • 6 minutes walking distance in m [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • WHO functional class [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    we will us the CAT-questionaire for QoL assessment
  • aminotransferase level (ASAT, ALAT) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Assessment of the aminotransferase levels in U/L
  • exhanled nitric oxide in parts per billion [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • hepatic venous pressure gradient (HVPG) in mmHg [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    HVPG will be assessed after inclusion in the study and after 3 months
  • pulmonary hemodynamics [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    pulmonary hemodynamics will be assessed after inclusion and after 3 months
  • mean arterial blood pressue in mmHg [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • partial pressure of arterial oxygen in mmHg [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Bosentan for Treatment of Hepatopulmonary Syndrome in Patients With Liver Cirrhosis
Bosentan for Treatment of Hepatopulmonary Syndrome in Patients With Liver Cirrhosis - a Prospective Double Blind Randomized Controlled Clinical Study

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Hepatopulmonary Syndrome
  • Liver Cirrhosis
  • Drug: bosentan
    pts. will receive bosentan for 3 months
  • Drug: Placebo
    pts. will receive placebo for 3 months
  • Placebo Comparator: placebo
    Patients will receive placebo tablets twice daily for 3 months.
    Intervention: Drug: Placebo
  • Active Comparator: bosentan
    pts. will receive bosentan for 3 months
    Intervention: Drug: bosentan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
18
Not Provided
October 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Valentin H Fuhrmann, MD 0043140404004741 valentin.fuhrmann@meduniwien.ac.at
Austria
 
NCT01518595
1-Fuhrmann
Not Provided
Valentin Fuhrmann, Medical University of Vienna
Medical University of Vienna
Not Provided
Principal Investigator: Valentin H Fuhrmann, MD Medical University Vienna
Medical University of Vienna
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP