{ "FullStudy":{ "Rank":217653, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01518595", "OrgStudyIdInfo":{ "OrgStudyId":"1-Fuhrmann" }, "Organization":{ "OrgFullName":"Medical University of Vienna", "OrgClass":"OTHER" }, "BriefTitle":"Bosentan for Treatment of Hepatopulmonary Syndrome in Patients With Liver Cirrhosis", "OfficialTitle":"Bosentan for Treatment of Hepatopulmonary Syndrome in Patients With Liver Cirrhosis - a Prospective Double Blind Randomized Controlled Clinical Study" }, "StatusModule":{ "StatusVerifiedDate":"September 2016", "OverallStatus":"Terminated", "WhyStopped":"too slow patient recruitment", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"October 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"April 2014", "PrimaryCompletionDateType":"Actual" }, "StudyFirstSubmitDate":"October 26, 2011", "StudyFirstSubmitQCDate":"January 25, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 26, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"September 27, 2016", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"September 28, 2016", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Valentin Fuhrmann", "ResponsiblePartyInvestigatorTitle":"MD, Associate Professor of Medicine", "ResponsiblePartyInvestigatorAffiliation":"Medical University of Vienna" }, "LeadSponsor":{ "LeadSponsorName":"Medical University of Vienna", "LeadSponsorClass":"OTHER" } }, "OversightModule":{}, "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." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Hepatopulmonary Syndrome", "Liver Cirrhosis" ] }, "KeywordList":{ "Keyword":[ "patients" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 2" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Quadruple", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Care Provider", "Investigator", "Outcomes Assessor" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"6", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"placebo", "ArmGroupType":"Placebo Comparator", "ArmGroupDescription":"Patients will receive placebo tablets twice daily for 3 months.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Placebo" ] } },{ "ArmGroupLabel":"bosentan", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"pts. will receive bosentan for 3 months", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: bosentan" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"bosentan", "InterventionDescription":"pts. will receive bosentan for 3 months", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "bosentan" ] } },{ "InterventionType":"Drug", "InterventionName":"Placebo", "InterventionDescription":"pts. will receive placebo for 3 months", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "placebo" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"alveolar-arterial oxygen gradient in mmHg", "PrimaryOutcomeTimeFrame":"3 months" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"presence of HPS", "SecondaryOutcomeDescription":"assessment via contrast enhanced transthoracic echocardiography and pulmonary function testing", "SecondaryOutcomeTimeFrame":"3 months" },{ "SecondaryOutcomeMeasure":"6 minutes walking distance in m", "SecondaryOutcomeTimeFrame":"3 months" },{ "SecondaryOutcomeMeasure":"WHO functional class", "SecondaryOutcomeTimeFrame":"3 months" },{ "SecondaryOutcomeMeasure":"quality of life", "SecondaryOutcomeDescription":"we will us the CAT-questionaire for QoL assessment", "SecondaryOutcomeTimeFrame":"3 months" },{ "SecondaryOutcomeMeasure":"aminotransferase level (ASAT, ALAT)", "SecondaryOutcomeDescription":"Assessment of the aminotransferase levels in U/L", "SecondaryOutcomeTimeFrame":"3 months" },{ "SecondaryOutcomeMeasure":"exhanled nitric oxide in parts per billion", "SecondaryOutcomeTimeFrame":"3 months" },{ "SecondaryOutcomeMeasure":"hepatic venous pressure gradient (HVPG) in mmHg", "SecondaryOutcomeDescription":"HVPG will be assessed after inclusion in the study and after 3 months", "SecondaryOutcomeTimeFrame":"3 months" },{ "SecondaryOutcomeMeasure":"pulmonary hemodynamics", "SecondaryOutcomeDescription":"pulmonary hemodynamics will be assessed after inclusion and after 3 months", "SecondaryOutcomeTimeFrame":"3 months" },{ "SecondaryOutcomeMeasure":"mean arterial blood pressue in mmHg", "SecondaryOutcomeTimeFrame":"3 months" },{ "SecondaryOutcomeMeasure":"partial pressure of arterial oxygen in mmHg", "SecondaryOutcomeTimeFrame":"3 months" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nPresence of HPS\nAge ≥ 18 years\n\nExclusion Criteria:\n\nIntracardiac shunting\nPregnancy\nKnown hypersensitivity to bosentan\nUse of glyburide\nUse of cyclosporin A\nElevation of aminotransferase level of > 3 times the upper limit of normal\nUse of rifampicin\nFemales of childbearing potential without use of adequate contraception\nSystolic blood pressure < 85 mmHg\nClinical relevant anemia\nHIV-infection", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Valentin H Fuhrmann, MD", "OverallOfficialAffiliation":"Medical University Vienna", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Medical University Vienna, Dpt. of Internal Medicine 3, Div. of Gastroenterology and Hepatology", "LocationCity":"Vienna", "LocationZip":"1090", "LocationCountry":"Austria" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000077300", "InterventionMeshTerm":"Bosentan" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000000959", "InterventionAncestorTerm":"Antihypertensive Agents" },{ "InterventionAncestorId":"D000065128", "InterventionAncestorTerm":"Endothelin Receptor Antagonists" },{ "InterventionAncestorId":"D000045504", "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M1753", "InterventionBrowseLeafName":"Bosentan", "InterventionBrowseLeafAsFound":"Bosentan", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M2858", "InterventionBrowseLeafName":"Antihypertensive Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M29053", "InterventionBrowseLeafName":"Endothelin Receptor Antagonists", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"AnAg", "InterventionBrowseBranchName":"Antihypertensive Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000008103", "ConditionMeshTerm":"Liver Cirrhosis" },{ "ConditionMeshId":"D000020065", "ConditionMeshTerm":"Hepatopulmonary Syndrome" },{ "ConditionMeshId":"D000013577", "ConditionMeshTerm":"Syndrome" },{ "ConditionMeshId":"D000005355", "ConditionMeshTerm":"Fibrosis" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000004194", "ConditionAncestorTerm":"Disease" },{ "ConditionAncestorId":"D000010335", "ConditionAncestorTerm":"Pathologic Processes" },{ "ConditionAncestorId":"D000008107", "ConditionAncestorTerm":"Liver Diseases" },{ "ConditionAncestorId":"D000004066", "ConditionAncestorTerm":"Digestive System Diseases" },{ "ConditionAncestorId":"D000008171", "ConditionAncestorTerm":"Lung Diseases" },{ "ConditionAncestorId":"D000012140", "ConditionAncestorTerm":"Respiratory Tract Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M9686", "ConditionBrowseLeafName":"Liver Cirrhosis", "ConditionBrowseLeafAsFound":"Liver Cirrhosis", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M14938", "ConditionBrowseLeafName":"Syndrome", "ConditionBrowseLeafAsFound":"Syndrome", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M20488", "ConditionBrowseLeafName":"Hepatopulmonary Syndrome", "ConditionBrowseLeafAsFound":"Hepatopulmonary Syndrome", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M7068", "ConditionBrowseLeafName":"Fibrosis", "ConditionBrowseLeafAsFound":"Cirrhosis", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M9690", "ConditionBrowseLeafName":"Liver Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M7466", "ConditionBrowseLeafName":"Gastrointestinal Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M5838", "ConditionBrowseLeafName":"Digestive System Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M9751", "ConditionBrowseLeafName":"Lung Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M13560", "ConditionBrowseLeafName":"Respiratory Tract Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"T2743", "ConditionBrowseLeafName":"Hepatopulmonary Syndrome", "ConditionBrowseLeafAsFound":"Hepatopulmonary Syndrome", "ConditionBrowseLeafRelevance":"high" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC06", "ConditionBrowseBranchName":"Digestive System Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" },{ "ConditionBrowseBranchAbbrev":"BC08", "ConditionBrowseBranchName":"Respiratory Tract (Lung and Bronchial) Diseases" },{ "ConditionBrowseBranchAbbrev":"Rare", "ConditionBrowseBranchName":"Rare Diseases" } ] } } } } } }