Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2025-12-31 @ 4:48 PM
Study NCT ID:
NCT00902603
Status:
TERMINATED
Last Update Posted:
2025-02-03
First Post:
2009-05-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ventavis® Registry Protocol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081029', 'term': 'Pulmonary Arterial Hypertension'}], 'ancestors': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016285', 'term': 'Iloprost'}], 'ancestors': [{'id': 'D011465', 'term': 'Prostaglandins, Synthetic'}, {'id': 'D011453', 'term': 'Prostaglandins'}, {'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 148}}, 'statusModule': {'whyStopped': 'low enrollment and difficulty recruiting eligible patients in adequate time', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-31', 'studyFirstSubmitDate': '2009-05-13', 'studyFirstSubmitQcDate': '2009-05-13', 'lastUpdatePostDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-05-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adherence with instructions for use of Ventavis®', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Persistence of use of Ventavis®', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pulmonary arterial hypertension', 'Ventavis®', 'iloprost'], 'conditions': ['Pulmonary Arterial Hypertension']}, 'descriptionModule': {'briefSummary': 'The Ventavis® (iloprost) Registry is a multicenter, observational, U.S.-based study that longitudinally follows patients with pulmonary arterial hypertension (PAH) who have been receiving therapy with Ventavis® for at least 3 months. Patients diagnosed with WHO Group I PAH who are on a stable regimen of commercial Ventavis® will be followed for a maximum of 2 years from the time of enrollment. Data will be collected via patient interview and review of the medical record. Quarterly data collection will include capture of medications and Ventavis® adherence data.', 'detailedDescription': 'The Ventavis® (iloprost) Registry is a multicenter, observational, U.S.-based study that longitudinally follows patients with pulmonary arterial hypertension (PAH) who have been receiving therapy with Ventavis® for at least 3 months. Patients diagnosed with WHO Group I PAH and who are on a stable regimen of commercial Ventavis® will be followed for a maximum of 2 years from the time of enrollment. All data will be collected via patient interview and/or review of the medical record, as well as from I-neb® downloads using INSIGHT software. Adherence with Ventavis® will be compared before and after targeted instruction on inhalation techniques by a respiratory therapist or designee, as well as before and after participation in PAH patient support groups (if applicable). Quarterly data collection will include capture of PAH and non-PAH medications and Ventavis® adherence data; Ventavis® adherence data will also be collected one month after study entry.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary Care Clinic', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Have a current diagnosis of WHO Group I PAH\n2. Have initiated therapy with commercial Ventavis® administered via portable nebulizer at least 3 months prior to study enrollment, either with commercial product or from participation in Actelion's Clinical Study AC-063A302\n3. Age \\> or = 18 years old at the time of enrollment\n\nExclusion Criteria:\n\n1. Meet the criteria for inclusion into WHO Groups II, III, IV or V PAH\n2. Are not currently on commercial Ventavis®\n3. Have initiated therapy with commercial Ventavis® administered via portable nebulizer less than 3 months prior to study enrollment"}, 'identificationModule': {'nctId': 'NCT00902603', 'acronym': 'RESPIRE', 'briefTitle': 'Ventavis® Registry Protocol', 'organization': {'class': 'INDUSTRY', 'fullName': 'Actelion'}, 'officialTitle': 'Registry to Prospectively Evaluate Use of Ventavis® in Patients With Pulmonary Arterial Hypertension', 'orgStudyIdInfo': {'id': 'AC-063A501'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Patients with WHO Group I pulmonary arterial hypertension (PAH) who have been receiving therapy with Ventavis® for at least 3 months.', 'interventionNames': ['Drug: Commercial Ventavis® (iloprost)']}], 'interventions': [{'name': 'Commercial Ventavis® (iloprost)', 'type': 'DRUG', 'description': 'Commercial Ventavis® (iloprost) administered via portable nebulizer (I-neb® AAD® system using the power disc-6)', 'armGroupLabels': ['1']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Actelion', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}