Ignite Creation Date:
2025-12-24 @ 12:03 PM
Ignite Modification Date:
2025-12-27 @ 9:34 PM
Study NCT ID:
NCT01639261
Status:
UNKNOWN
Last Update Posted:
2012-07-12
First Post:
2012-07-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase II Trial on Treatment of Steroid-refractory Bronchiolitis Obliterans With Interferon Gamma 1b After Allogeneic SCT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}], 'ancestors': [{'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007371', 'term': 'Interferon-gamma'}], 'ancestors': [{'id': 'D007372', 'term': 'Interferons'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D016215', 'term': 'Macrophage-Activating Factors'}, {'id': 'D008222', 'term': 'Lymphokines'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2014-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-07-11', 'studyFirstSubmitDate': '2012-07-09', 'studyFirstSubmitQcDate': '2012-07-11', 'lastUpdatePostDateStruct': {'date': '2012-07-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'therapy response', 'timeFrame': '24 weeks', 'description': 'Enhancement of therapy response from 15 % to 50 %'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['steroid-refractory', 'bronchiolitis obliterans', 'allogeneic stem cell transplantation', 'interferon gamma'], 'conditions': ['Steroid-refractory Bronchiolitis Obliterans']}, 'descriptionModule': {'briefSummary': 'Improvement of quality of life in patients with BO and establishment of a new third line therapy', 'detailedDescription': 'Primary Objectives:\n\nObjective improvement of lung function, i.e.:\n\n* Improvement of SO2, pO2 or pCO2 in oxygen dependent or improvement of FiO2 in respiration dependent patients ≥ 20 % or\n* Reduction of oxygen need in oxygen dependent patients ≥ 1L O2/min with constant parameters at blood gas analysis (BGA) or\n* Improvement of obstructive parameters ≥ 20 % or\n* Improvement of lung function score (LFS) at least about one grade Improvement of lung function should be detectable at least by two consecutive examinations of lung function or BGA within at least four weeks.\n\nSecondary Objectives\n\n* Morphological improvement of BO/BOOP at CT scan\n* Reduction of steroids about at least 20 %'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Allogeneic SCT\n* Age ≥ 18 years\n* BO, firmed by 2 out of 3 examinations:\n\n * Lung function/ BGA\n * CT scan in in- and expiration or\n * Histological diagnosis\n* Therapy refractory BO, i.e. no improvement during at least three therapies, among:\n\n * Azithromycin + inhaled steroids/ bronchodilators\n * Systemic steroids 1 mg/kg BW\n * One of the following therapies: MMF, mTOR inhibitors or ECP\n* Effective contraception (before, during and for 8 weeks after the treatment)\n* Blood count: no severe neutropenia, defined as ANC \\> 1000/ml, platelets \\> 50/nl and haemoglobin \\> 8 g/dl\n* Liver parameters (bilirubin, gammaGT, AP, ASAT, ALAT) lower than 3 x paramount normal range\n* Kreatinin lower than 3 x paramount normal range\n* Informed consent\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* Pregnant or nursing woman\n* No appropriate contraception\n* Participation in any other study within 4 weeks before or during the study\n* Active acute GvHD of other organs than the lung \\> grade II or severe active chronic GvHD\n* No appropriate antibiotic/ antimycotic therapy in documented infection\n* Severe bone marrow suppression (ANC \\< 1000/ml) or graft failure\n* Liver parameters (bilirubin, gammaGT, AP, ASAT and ALAT) higher than 3 x paramount normal range\n* Kreatinin higher than 3 x paramount normal range\n* Participation in another study within 4 weeks before or during the study'}, 'identificationModule': {'nctId': 'NCT01639261', 'acronym': 'IFN_BOSZT_01', 'briefTitle': 'A Phase II Trial on Treatment of Steroid-refractory Bronchiolitis Obliterans With Interferon Gamma 1b After Allogeneic SCT', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Regensburg'}, 'officialTitle': 'Eine Phase II Studie über Interferon Gamma 1b Zur Behandlung Der steroidrefraktären Bronchiolitis Obliterans Nach Allogener SZT', 'orgStudyIdInfo': {'id': 'IFN_BOSZT_01'}, 'secondaryIdInfos': [{'id': '2010-022467-36', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Interferon gamma 1b', 'type': 'DRUG', 'otherNames': ['Imukin'], 'description': 'Initial dose: 50µg s.c. three times/week, without fever \\>38,5 dose increase: 50µg/m² BSA three times/week'}]}, 'contactsLocationsModule': {'locations': [{'zip': '93053', 'city': 'Regensburg', 'country': 'Germany', 'facility': 'University Hospital Regensburg', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}], 'overallOfficials': [{'name': 'Ernst Holler, Professor MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Regensburg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Regensburg', 'class': 'OTHER'}, 'collaborators': [{'name': 'ClinAssess GmbH', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior physician', 'investigatorFullName': 'Professor Ernst Holler MD', 'investigatorAffiliation': 'University Hospital Regensburg'}}}}