Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2026-03-11 @ 11:58 AM
Study NCT ID:
NCT00625469
Status:
WITHDRAWN
Last Update Posted:
2018-03-06
First Post:
2008-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Fibrosis and Treatment With Bosentan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081029', 'term': 'Pulmonary Arterial Hypertension'}, {'id': 'D054990', 'term': 'Idiopathic Pulmonary Fibrosis'}], 'ancestors': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D011658', 'term': 'Pulmonary Fibrosis'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}]}, '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'competing studies did not allow enrollment', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-02', 'studyFirstSubmitDate': '2008-02-19', 'studyFirstSubmitQcDate': '2008-02-19', 'lastUpdatePostDateStruct': {'date': '2018-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-02-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '6 minute walk distance', 'timeFrame': 'monthly assessement until date of lung transplantation', 'description': 'ATS Guideline 6MW distance before and after intervention'}], 'secondaryOutcomes': [{'measure': 'right heart catheterization hemodynamics', 'timeFrame': 'variable based on time between listing and actual lung transplantation', 'description': 'pulmonary hemodynamics'}, {'measure': 'chemokine peripheral blood analysis', 'timeFrame': 'monthly', 'description': 'battery of chemokines analyzed from the peripheral blood'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True}, 'conditionsModule': {'keywords': ['pulmonary arterial hypertension', 'idiopathic pulmonary fibrosis', 'bosentan'], 'conditions': ['Pulmonary Arterial Hypertension', 'Idiopathic Pulmonary Fibrosis']}, 'descriptionModule': {'briefSummary': 'Pulmonary Arterial Hypertension (PAH) in the setting of Idiopathic Pulmonary Fibrosis(IPF)is a risk factor for morbidity and mortality in the peri-lung transplant(LT) setting. Currently there is no significant data to support the use of pulmonary vasodilators for PAH in the setting of interstitial lung disease such as IPF. The majority of IPF patients have PAH either at rest or during exercise. The study hypothesis is that bosentan may improve morbidity and mortality in the peri-LT setting in both IPF cohorts with either resting or exercise PAH.', 'detailedDescription': 'The purpose of this study was to evaluate bosentan in the setting of exercise or resting pulmonary hypertension in patients with underlying pulmonary fibrosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Idiopathic Pulmonary Fibrosis referred for lung transplantation\n* Minimum 50 meter 6 minute walk distance\n* No significant underlying liver disease\n\nExclusion Criteria:\n\n* Significant liver disease or cirrhosis\n* non ambulatory\n* previous adverse reaction/allergy to Bosentan'}, 'identificationModule': {'nctId': 'NCT00625469', 'briefTitle': 'Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Fibrosis and Treatment With Bosentan', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'Treatment of Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Hypertension With Bosentan: A Single Center Pilot Study', 'orgStudyIdInfo': {'id': 'IPF/PAH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'treatment with bosentan', 'description': 'patients with resting or exercise induced PAH receive bosentan in a randomized open label fashion', 'interventionNames': ['Drug: bosentan']}, {'type': 'NO_INTERVENTION', 'label': 'PAH group with no therapy', 'description': 'patients with resting or exercise PAH get randomized to receive no specific therapy'}, {'type': 'NO_INTERVENTION', 'label': 'No PAH and no therapy', 'description': 'patients with no evidence of either resting or exercise PAH receive no intervention but are followed until lung transplantation'}], 'interventions': [{'name': 'bosentan', 'type': 'DRUG', 'otherNames': ['tracleer'], 'description': '62.5mg orally bid for first month, followed by 125mg bid thereafter', 'armGroupLabels': ['treatment with bosentan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095-1690', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'David Geffen School of Medicine UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095-1690', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Departments of Pulmonary and Critical Care, Cardiothoracic Surgery and Infectious Diseases at David Geffen School of Medicine at UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Rajan Saggar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rajan Saggar', 'class': 'OTHER'}, 'collaborators': [{'name': 'Actelion', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Rajan Saggar', 'investigatorAffiliation': 'University of California, Los Angeles'}}}}