Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-27 @ 10:10 PM
Study NCT ID:
NCT00919451
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2009-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ciclosporin in the Management of Steroid Resistant Type 1 Reactions in Leprosy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007918', 'term': 'Leprosy'}], 'ancestors': [{'id': 'D009165', 'term': 'Mycobacterium Infections, Nontuberculous'}, {'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016572', 'term': 'Cyclosporine'}], 'ancestors': [{'id': 'D003524', 'term': 'Cyclosporins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-24', 'studyFirstSubmitDate': '2009-06-11', 'studyFirstSubmitQcDate': '2009-06-11', 'lastUpdatePostDateStruct': {'date': '2015-03-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'improvement in nerve function', 'timeFrame': 'at 24 weeks and 32 weeks'}], 'secondaryOutcomes': [{'measure': 'incidence of adverse effects', 'timeFrame': 'throughout 32 weeks'}, {'measure': 'Skin lesion inflammation improvement', 'timeFrame': 'up to 36 weeks'}, {'measure': 'rate of improvement of reaction', 'timeFrame': 'up to 36 weeks'}, {'measure': 'Time to next reactional episode', 'timeFrame': 'up to 2 years'}, {'measure': 'extra prednisolone needed to control reaction', 'timeFrame': 'up to 36 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Leprosy', 'Type 1 Reaction', 'Prednisolone', 'Ciclosporin'], 'conditions': ['Leprosy']}, 'descriptionModule': {'briefSummary': 'Study 1B: Ciclosporin in the management of steroid resistant Type 1 Reactions in Leprosy\n\nObjective: A pilot study assessing the efficacy and safety of Ciclosporin as a second -line drug in patients with Type 1 Reactions who have not responded to a 12 week course of Prednisolone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals with clinical evidence of Type 1 Reaction who have not responded to 3 months Prednisolone Treatment\n* Aged 18-65\n* Weigh more than 30Kg\n\nExclusion Criteria:\n\n* Unwillingness to give informed consent\n* Patients with severe active infections such as tuberculosis\n* Pregnant or breastfeeding women (see Appendix II)\n* Those with renal failure, abnormal renal function, hypertensive\n* Patients taking thalidomide currently or within the last 3 months\n* Patients not willing to return for follow-up\n* Women of reproductive age not willing to use contraception for the duration of the study ( see Appendix II)\n* HIV positive'}, 'identificationModule': {'nctId': 'NCT00919451', 'briefTitle': 'Ciclosporin in the Management of Steroid Resistant Type 1 Reactions in Leprosy', 'organization': {'class': 'OTHER', 'fullName': 'London School of Hygiene and Tropical Medicine'}, 'officialTitle': 'A Pilot Study Assessing the Efficacy and Safety of Ciclosporin as a Second -Line Drug in Patients With Type 1 Reactions Who Have Not Responded to a 12 Week Course of Prednisolone.', 'orgStudyIdInfo': {'id': 'ITCRBY24-T1RB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ciclosporin', 'description': 'ciclosporin reducing regimen lasting 24 weeks (additional prednisolone given for the first four weeks)', 'interventionNames': ['Drug: ciclosporin']}], 'interventions': [{'name': 'ciclosporin', 'type': 'DRUG', 'description': 'Ciclosporin 7.5mg/kg - reducing regimen over 24 weeks (additional prednisolone given for the first four weeks)', 'armGroupLabels': ['Ciclosporin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Addis Ababa', 'country': 'Ethiopia', 'facility': 'Alert Hospital', 'geoPoint': {'lat': 9.02497, 'lon': 38.74689}}], 'overallOfficials': [{'name': 'Diana NJ Lockwood, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'London SHTM'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'London School of Hygiene and Tropical Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Homes and Hospitals of St Giles', 'class': 'OTHER'}, {'name': 'Alert Hospital, Ethiopia', 'class': 'OTHER'}, {'name': 'Armauer Hansen Research Institute, Ethiopia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}