Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2025-12-30 @ 8:17 PM
Study NCT ID:
NCT00076635
Status:
TERMINATED
Last Update Posted:
2007-11-06
First Post:
2004-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open-Label Study of the Safety of Interferon Gamma-1b in Patients With IPF
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054990', 'term': 'Idiopathic Pulmonary Fibrosis'}, {'id': 'D011658', 'term': 'Pulmonary Fibrosis'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C554125', 'term': 'interferon gamma-1b'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91}}, 'statusModule': {'whyStopped': 'program discontinued based on GIPF-007 results', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2003-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-11', 'completionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-11-02', 'studyFirstSubmitDate': '2004-01-28', 'studyFirstSubmitQcDate': '2004-01-29', 'lastUpdatePostDateStruct': {'date': '2007-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All adverse events up to the end of study', 'timeFrame': '3.5 years'}, {'measure': 'Survival status at end of study', 'timeFrame': '3.5 years'}, {'measure': 'Serum antibodies to Interferon gamma-1b after the last injection.', 'timeFrame': '3.5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Idiopathic', 'Pulmonary', 'Fibrosis', 'IPF', 'Lung', 'Actimmune', 'Interferon', 'Gamma', 'InterMune'], 'conditions': ['Idiopathic Pulmonary Fibrosis', 'Pulmonary Fibrosis', 'Lung Disease']}, 'descriptionModule': {'briefSummary': 'Open-label therapy will be administered to up to 220 patients, following completion of either InterMune Protocol GIPF-002 Part B or Protocol GIPF-004, to assess the long-term safety of subcutaneous Interferon gamma-1b. The study duration will be 5 years.', 'detailedDescription': 'Open-label therapy will be administered subcutaneously. Patients enrolled will continue to receive Interferon gamma-1b therapy three times per week and will be evaluated at 6-week intervals. Patients not taking Interferon gamma-1b at enrollment will re-initiate therapy with subcutaneous Interferon gamma-1b under a dose-escalation scheme, reaching full dose after 2 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Enrollment in Protocol GIPF 002 Part B or GIPF-004\n* Completion of the End of Treatment Visit in Protocol GIPF-002 Part B or the Study Completion Visit in GIPF-004\n* Able to understand and sign a written informed consent form and comply with the requirements of the study\n\nExclusion criteria:\n\n* pregnancy or lactation\n* lack of adherence to either GIPF-002 or GIPF-004 study protocols and treatment regimens\n* if Principal Investigator deems patient is unsuitable for study'}, 'identificationModule': {'nctId': 'NCT00076635', 'briefTitle': 'An Open-Label Study of the Safety of Interferon Gamma-1b in Patients With IPF', 'organization': {'class': 'INDUSTRY', 'fullName': 'InterMune'}, 'officialTitle': 'An Open-Label Study of the Safety of Subcutaneous Recombinant Interferon Gamma-1b in Patients With Idiopathic Pulmonary Fibrosis', 'orgStudyIdInfo': {'id': 'GIPF-006'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Interferon gamma-1b', 'type': 'DRUG', 'description': '200 mcg, SQ, 3x per week'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94005', 'city': 'Brisbane', 'state': 'California', 'country': 'United States', 'facility': 'Intermune Inc', 'geoPoint': {'lat': 37.68077, 'lon': -122.39997}}], 'overallOfficials': [{'name': 'InterMune, Inc. 888-486-6411', 'affiliation': 'Medical Information'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'InterMune', 'class': 'INDUSTRY'}}}}