Ignite Creation Date:
2025-12-24 @ 5:50 PM
Ignite Modification Date:
2026-02-21 @ 11:35 PM
Study NCT ID:
NCT02603068
Status:
WITHDRAWN
Last Update Posted:
2016-02-09
First Post:
2015-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Treprostinil in Subjects With Pulmonary Hypertension Associated With Pulmonary Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D011658', 'term': 'Pulmonary Fibrosis'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C427248', 'term': 'treprostinil'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study design was inadequate and would not achieve study endpoints', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-02-05', 'studyFirstSubmitDate': '2015-11-10', 'studyFirstSubmitQcDate': '2015-11-10', 'lastUpdatePostDateStruct': {'date': '2016-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in pulmonary vascular resistance (PVR)', 'timeFrame': 'Baseline to Week 16', 'description': 'Change in PVR between iMTD and fixed dose groups'}], 'secondaryOutcomes': [{'measure': 'Change in Six-minute walk distance (6MWD)', 'timeFrame': 'Baseline to Week 16', 'description': 'Change in 6MWD between iMTD and fixed dose groups'}, {'measure': 'Change in N-terminal pro-brain natriuretic peptide (NT-ProBNP)', 'timeFrame': 'Baseline to Week 16', 'description': 'Change in NT-ProBNP between iMTD and fixed dose groups'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pulmonary Hypertension', 'Pulmonary Fibrosis']}, 'descriptionModule': {'briefSummary': 'This multicenter, randomized, open-label study will assess the safety and efficacy of oral treprostinil in subjects diagnosed with pulmonary hypertension associated with pulmonary fibrosis.', 'detailedDescription': 'This study will evaluate how oral treprostinil can affect pulmonary vascular resistance, as assessed by right heart catheterization, and exercise capacity, as assessed by the Six-Minute Walk Test. This is a 16-week study that will involve at least 10 clinical trial centers. The expected enrollment period is around 24 months and 52 subjects will be entered into the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Voluntarily gives informed consent\n* Must meet criteria for lung transplant referral but is not required to be on an active lung transplant list\n* Stable and significant diffuse parenchymal lung disease with a diagnosis of interstitial lung disease\n* 6MWD greater than or equal to 75 meters\n* Right heart catheterization with a mean pulmonary arterial pressure \\>= 30 mgHg, pulmonary capillary wedge pressure \\<= 15 mmHg and pulmonary vascular resistance \\> 240 dynes\n* Echo-Doppler examination showing evidence of right ventricular dysfunction and normal left diastolic ventricular function\n* Either not receiving any PAH-approved oral therapy, or is receiving monotherapy (ERA, PDE-5I, or riociguat) for \\> 60 days and receiving a stable dose for \\> 30 days prior to enrollment\n* Able to communicate effectively with study personnel and will to be cooperative with protocol requirements\n\nExclusion Criteria:\n\n* History of repaired or unrepaired congenital heart disease\n* Received prostanoid therapy in the past 30 days, or has shown an intolerance or lack of efficacy to prostanoid therapy resulting in discontinuation or inability to titrate prostacyclins\n* Diagnosis of sarcoidosis\n* History of thromboembolic disease\n* Chronic renal insufficiency\n* Pregnancy or lactating\n* Currently receiving an investigational drug, has an investigational device in place, or has participated in an investigational drug or device study within 30 days prior to Screening'}, 'identificationModule': {'nctId': 'NCT02603068', 'briefTitle': 'Oral Treprostinil in Subjects With Pulmonary Hypertension Associated With Pulmonary Fibrosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'United Therapeutics'}, 'officialTitle': 'Multicenter, Randomized, Open Label Trial to Evaluate the Safety and Efficacy of Oral Treprostinil in Subjects With Pulmonary Hypertension Associated With Pulmonary Fibrosis', 'orgStudyIdInfo': {'id': 'TDE-PH-204'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Individual Maximum Tolerated Dose (iMTD)', 'description': 'Subjects are allowed to titrate oral treprostinil up to a maximum dose of 12 mg TID.', 'interventionNames': ['Drug: Oral treprostinil']}, {'type': 'EXPERIMENTAL', 'label': 'Fixed Dose (FD)', 'description': 'Subjects are allowed to titrate oral treprostinil up to a maximum dose of 1 mg TID.', 'interventionNames': ['Drug: Oral treprostinil']}], 'interventions': [{'name': 'Oral treprostinil', 'type': 'DRUG', 'otherNames': ['Orenitram'], 'description': 'Oral treprostinil will be administered as TID dosing for up to 16 Weeks.', 'armGroupLabels': ['Fixed Dose (FD)', 'Individual Maximum Tolerated Dose (iMTD)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner University Medical Center Phoenix Advanced Lung Disease', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90024', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Los Angeles - Pulmonary Division', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California - Davis Medical Group', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '21205', 'city': 'Baltiomore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University'}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'CLC Pulmonary Hypertension Clinic Division of Pulmonary, Allergy and Critical Care Medicine UPMC', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Rajan Saggar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles - Pulmonary Division'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Study is withdrawn. There is no data to share.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'United Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}