NCT01518595

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2011

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 26, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Last Updated

September 28, 2016

Status Verified

September 1, 2016

Enrollment Period

2.5 years

First QC Date

October 26, 2011

Last Update Submit

September 27, 2016

Conditions

Hepatopulmonary SyndromeLiver Cirrhosis

Keywords

patients

Outcome Measures

Primary Outcomes (1)

  • alveolar-arterial oxygen gradient in mmHg

    3 months

Secondary Outcomes (10)

  • presence of HPS

    3 months

  • 6 minutes walking distance in m

    3 months

  • WHO functional class

    3 months

  • quality of life

    3 months

  • aminotransferase level (ASAT, ALAT)

    3 months

  • +5 more secondary outcomes

Study Arms (2)

placebo

PLACEBO COMPARATOR

Patients will receive placebo tablets twice daily for 3 months.

Drug: Placebo

bosentan

ACTIVE COMPARATOR

pts. will receive bosentan for 3 months

Drug: bosentan

Interventions

bosentanDRUG

pts. will receive bosentan for 3 months

bosentan
PlaceboDRUG

pts. will receive placebo for 3 months

placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Presence of HPS
  • Age ≥ 18 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Vienna, Dpt. of Internal Medicine 3, Div. of Gastroenterology and Hepatology

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Hepatopulmonary SyndromeLiver Cirrhosis

Interventions

Bosentan

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Valentin H Fuhrmann, MD

    Medical University Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Associate Professor of Medicine

Study Record Dates

First Submitted

October 26, 2011

First Posted

January 26, 2012

Study Start

October 1, 2011

Primary Completion

April 1, 2014

Last Updated

September 28, 2016

Record last verified: 2016-09

Locations

AU(1)