Ignite Creation Date:
2025-12-24 @ 2:01 PM
Ignite Modification Date:
2025-12-25 @ 12:46 PM
Study NCT ID:
NCT01518595
Status:
TERMINATED
Last Update Posted:
2016-09-28
First Post:
2011-10-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bosentan for Treatment of Hepatopulmonary Syndrome in Patients With Liver Cirrhosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020065', 'term': 'Hepatopulmonary Syndrome'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077300', 'term': 'Bosentan'}], 'ancestors': [{'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'whyStopped': 'too slow patient recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'lastUpdateSubmitDate': '2016-09-27', 'studyFirstSubmitDate': '2011-10-26', 'studyFirstSubmitQcDate': '2012-01-25', 'lastUpdatePostDateStruct': {'date': '2016-09-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'alveolar-arterial oxygen gradient in mmHg', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'presence of HPS', 'timeFrame': '3 months', 'description': 'assessment via contrast enhanced transthoracic echocardiography and pulmonary function testing'}, {'measure': '6 minutes walking distance in m', 'timeFrame': '3 months'}, {'measure': 'WHO functional class', 'timeFrame': '3 months'}, {'measure': 'quality of life', 'timeFrame': '3 months', 'description': 'we will us the CAT-questionaire for QoL assessment'}, {'measure': 'aminotransferase level (ASAT, ALAT)', 'timeFrame': '3 months', 'description': 'Assessment of the aminotransferase levels in U/L'}, {'measure': 'exhanled nitric oxide in parts per billion', 'timeFrame': '3 months'}, {'measure': 'hepatic venous pressure gradient (HVPG) in mmHg', 'timeFrame': '3 months', 'description': 'HVPG will be assessed after inclusion in the study and after 3 months'}, {'measure': 'pulmonary hemodynamics', 'timeFrame': '3 months', 'description': 'pulmonary hemodynamics will be assessed after inclusion and after 3 months'}, {'measure': 'mean arterial blood pressue in mmHg', 'timeFrame': '3 months'}, {'measure': 'partial pressure of arterial oxygen in mmHg', 'timeFrame': '3 months'}]}, 'conditionsModule': {'keywords': ['patients'], 'conditions': ['Hepatopulmonary Syndrome', 'Liver Cirrhosis']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presence of HPS\n* Age ≥ 18 years\n\nExclusion Criteria:\n\n* Intracardiac shunting\n* Pregnancy\n* Known hypersensitivity to bosentan\n* Use of glyburide\n* Use of cyclosporin A\n* Elevation of aminotransferase level of \\> 3 times the upper limit of normal\n* Use of rifampicin\n* Females of childbearing potential without use of adequate contraception\n* Systolic blood pressure \\< 85 mmHg\n* Clinical relevant anemia\n* HIV-infection'}, 'identificationModule': {'nctId': 'NCT01518595', 'briefTitle': 'Bosentan for Treatment of Hepatopulmonary Syndrome in Patients With Liver Cirrhosis', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Bosentan for Treatment of Hepatopulmonary Syndrome in Patients With Liver Cirrhosis - a Prospective Double Blind Randomized Controlled Clinical Study', 'orgStudyIdInfo': {'id': '1-Fuhrmann'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'Patients will receive placebo tablets twice daily for 3 months.', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'bosentan', 'description': 'pts. will receive bosentan for 3 months', 'interventionNames': ['Drug: bosentan']}], 'interventions': [{'name': 'bosentan', 'type': 'DRUG', 'description': 'pts. will receive bosentan for 3 months', 'armGroupLabels': ['bosentan']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'pts. will receive placebo for 3 months', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Medical University Vienna, Dpt. of Internal Medicine 3, Div. of Gastroenterology and Hepatology', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Valentin H Fuhrmann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University Vienna'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Associate Professor of Medicine', 'investigatorFullName': 'Valentin Fuhrmann', 'investigatorAffiliation': 'Medical University of Vienna'}}}}