Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-26 @ 1:47 AM
Study NCT ID:
NCT01424033
Status:
TERMINATED
Last Update Posted:
2017-04-06
First Post:
2011-08-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Clinical Trial for CTD-ILD Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D045743', 'term': 'Scleroderma, Diffuse'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D012859', 'term': "Sjogren's Syndrome"}, {'id': 'D008947', 'term': 'Mixed Connective Tissue Disease'}, {'id': 'D003882', 'term': 'Dermatomyositis'}, {'id': 'D017285', 'term': 'Polymyositis'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012595', 'term': 'Scleroderma, Systemic'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D014987', 'term': 'Xerostomia'}, {'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D015352', 'term': 'Dry Eye Syndromes'}, {'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D009220', 'term': 'Myositis'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000111', 'term': 'Acetylcysteine'}], 'ancestors': [{'id': 'D003545', 'term': 'Cysteine'}, {'id': 'D000603', 'term': 'Amino Acids, Sulfur'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'janstev@med.umich.edu', 'phone': '7349365566', 'title': 'Jan Stevens', 'organization': 'University of Michigan'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Five subjects were consented. Study was terminated prior to conclusion due to departure of PI.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'N-Acetylcysteine', 'description': 'This is an open label trial, all patient will be entered into one treatment arm.\n\nN-Acetylcysteine: 600mg by mouth, three times daily for 12 months', 'otherNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'seriousNumAffected': 3}], 'seriousEvents': [{'term': 'Cancer recurrence', 'notes': 'Patient with a known history of cancer had a recurrence of breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Death', 'notes': 'Patient with rapid decline in her health due to new onset scleroderma, pulmonary fibrosis, and cardiac arrhythmia.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization, tachycardia', 'notes': 'Patient with known history of cardiac disease and tachycardia was hospitalized with tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pulmonary Function Tests', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'N-Acetylcysteine', 'description': 'This is an open label trial, all patient will be entered into one treatment arm.\n\nN-Acetylcysteine: 600mg by mouth, three times daily for 12 months'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'timeFrame': 'Every 3 months', 'description': 'Not recorded. Study terminated due to departure of PI.', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'N-Acetylcysteine', 'description': 'This is an open label trial, all patient will be entered into one treatment arm.\n\nN-Acetylcysteine: 600mg by mouth, three times daily for 12 months'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}], 'recruitmentDetails': '5 subjects consented but did not participate in study due to departure of PI from institution.', 'preAssignmentDetails': '5 subjects consented to participate due to the PI departed the institution. Numbers in patient flow were updated to reflect this.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'N-Acetylcysteine', 'description': 'This is an open label trial, all patient will be entered into one treatment arm.\n\nN-Acetylcysteine: 600mg by mouth, three times daily for 12 months'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50', 'spread': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'Departure of study team', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'lastUpdateSubmitDate': '2017-02-22', 'studyFirstSubmitDate': '2011-08-24', 'resultsFirstSubmitDate': '2016-01-14', 'studyFirstSubmitQcDate': '2011-08-25', 'lastUpdatePostDateStruct': {'date': '2017-04-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-01-14', 'studyFirstPostDateStruct': {'date': '2011-08-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pulmonary Function Tests', 'timeFrame': 'Every 3 months', 'description': 'Not recorded. Study terminated due to departure of PI.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Interstitial lung disease', 'Connective tissue disease', 'Scleroderma', 'Rheumatoid arthritis', "Sjogren's syndrome", 'Mixed connective tissue disease', 'Dermatomyositis', 'Polymyositis', 'Systemic lupus erythematosis'], 'conditions': ['Interstitial Lung Disease', 'Connective Tissue Disease']}, 'descriptionModule': {'briefSummary': 'The first objective of this protocol is to assess the tolerability and safety of N-acetylcysteine (NAC) in patients with connective tissue disease related interstitial lung disease (CTD-ILD).', 'detailedDescription': 'The investigators will assess tolerability and safety at scheduled intervals via standard of care physical exam findings, monitoring complete blood count, serum chemistry, and pulmonary function tests, along with patient reports of medication intolerance and change in symptoms of dyspnea.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion:\n\n1. Subject gives voluntary written informed consent to participate in the study.\n2. Subject has been diagnosed with a connective tissue disease and associated interstitial lung disease confirmed by computed tomography of the lungs along with symptoms of cough and/or shortness of breath.\n3. Males and females age greater than 18 years at time of screening.\n4. Females of childbearing potential must be willing to use a reliable form of medically acceptable contraception and have a negative pregnancy test confirmed at baseline before starting NAC as per standard of care. Women who are surgically sterile or have been post-menopausal for at least two years are not considered to be of child-bearing potential.\n\nExclusion:\n\n1. History of severe chronic kidney disease defined as a glomerular filtration rate of less than 30.\n2. Hemoglobin concentration less than 70% of the lower limit of the normal range at time of screening.\n3. Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C.'}, 'identificationModule': {'nctId': 'NCT01424033', 'briefTitle': 'A Clinical Trial for CTD-ILD Treatment', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Clinical Trial of Oral Medication for CTD-ILD Treatment', 'orgStudyIdInfo': {'id': 'HUM00049434'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'N-Acetylcysteine', 'description': 'This is an open label trial, all patient will be entered into one treatment arm.', 'interventionNames': ['Drug: N-Acetylcysteine']}], 'interventions': [{'name': 'N-Acetylcysteine', 'type': 'DRUG', 'otherNames': ['NAC', 'acetylcysteine'], 'description': '600mg by mouth, three times daily for 12 months', 'armGroupLabels': ['N-Acetylcysteine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Kristine Phillips', 'investigatorAffiliation': 'University of Michigan'}}}}