Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2025-12-28 @ 8:46 PM
Study NCT ID:
NCT06288932
Status:
COMPLETED
Last Update Posted:
2024-11-06
First Post:
2024-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcome Study of Conventional Steroids Vs. Steroids Combined with Mycopehnolate in Newly Diagnosed Immune Thrombocytopenia Purpura.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009173', 'term': 'Mycophenolic Acid'}, {'id': 'D013812', 'term': 'Therapeutics'}], 'ancestors': [{'id': 'D002208', 'term': 'Caproates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study will comprise the newly diagnosed patients of Immune thrombocytopenia purpura aged 5-60 year. Patients will with a 1:1 ratio among the two group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-08-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-04', 'studyFirstSubmitDate': '2024-02-16', 'studyFirstSubmitQcDate': '2024-02-29', 'lastUpdatePostDateStruct': {'date': '2024-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Platelet count monitoring', 'timeFrame': 'assessed after 3 months and 6 months of treatment.', 'description': 'Platelet count improvement, as assessed through regular monitoring and according to response criteria:\n\nThe response criteria to the treatment described as follow:\n\n1. Complete response: Platelet count ≥ 100 x 10\\^ 9 /L\n2. Partial response: Platelet count 30≥ 100 x 10 \\^9 /L\n3. No response: Platelet count 30 x 10\\^9 /'}], 'secondaryOutcomes': [{'measure': 'Assessment of Health-Related Quality of Life questionnaire', 'timeFrame': '12 months', 'description': 'Health-related quality of life questionnaire'}, {'measure': 'Incidence of adverse events', 'timeFrame': '12 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ITP', 'MMF'], 'conditions': ['Immune Thrombocytopenia Purpura']}, 'descriptionModule': {'briefSummary': 'Immune thrombocytopenia Purpura (ITP) is an autoimmune condition delineated by humoral as well as cell mediated immune response against thrombocyte surface proteins GPIIb/IIIa receptors, affecting primary homeostasis leading to mucocutaneous bleeding.ITP is characterized by platelet count \\<100 x 109/L. The conventional line of treatment for newly diagnosed ITP is steroids but significant disadvantages have been associated with long term use and a high risk of relapse when reducing the dose. The addition of MMF to the first line treatment of ITP resulted in substantial response and a lower risk of refractory ITP with decreased financial burden and improved outcome.', 'detailedDescription': 'Immune Thrombocytopenia Purpura (ITP) is an acquired, immune-mediated disorder characterized by a severe decrease in peripheral thrombocyte count to less than 100 x 10⁹/L, leading to mucocutaneous bleeding. Our primary objective is to evaluate the efficacy of adding Mycophenolate Mofetil (MMF) alongside steroids in the first-line treatment of ITP, aiming for an enhanced therapeutic response, lower risk of refractory and chronic ITP, reduced financial burden, and improved overall outcomes.\n\nThe study aims to validate the efficacy and safety of MMF as a first-line treatment option for ITP while reducing the economic burden and risk of relapse associated with the condition'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Requirements:\n\n• Age: 5-60 years • Number of plates: \\<30x109\n\nExclusion Standards:\n\nPregnancy; lactation; hepatitis B and C; HIV-reactive individuals; and medication allergies'}, 'identificationModule': {'nctId': 'NCT06288932', 'briefTitle': 'Outcome Study of Conventional Steroids Vs. Steroids Combined with Mycopehnolate in Newly Diagnosed Immune Thrombocytopenia Purpura.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Institute of Blood and Marrow Transplant (NIBMT), Pakistan'}, 'officialTitle': 'An Outcome Study of Conventional Steroids Vs. Steroids Combined with Mycophenolate for the Management of Newly Diagnosed Immune Thrombocytopenia Purpura: a Cost Effective Measure in Developing Nations.', 'orgStudyIdInfo': {'id': 'NIBD/IRB-263/08-2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mycophenolate Mofetil (MMF) Treatment', 'description': 'Patients in this arm will receive Mycophenolate Mofetil (MMF) at a starting dose of 500mg twice daily along with Prednisolone.\n\nThe pediatric dose of MMF will be calculated by 30mg/kg/day. Dose adjustment will be based on treatment response, with potential increases to 750mg twice daily or 1g twice daily.\n\nMMF will be administered for a specific duration, as determined by the study design.', 'interventionNames': ['Drug: Mycophenolate Mofetil (MMF) Treatment']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Treatment Control', 'description': 'Patients in this arm will receive the standard treatment for ITP, which may include corticosteroids (prednisolone) commonly used for ITP management.The treatment regimen will be determined based on current standard guidelines and clinical practice.'}], 'interventions': [{'name': 'Mycophenolate Mofetil (MMF) Treatment', 'type': 'DRUG', 'otherNames': ['Suprimun'], 'description': 'The first-line treatment of immune thrombocytopenia purpura with Mycophenolate Mofetil produced a significant response, a lowered likelihood of refractory ITP, a better outcome, and less financial burden.', 'armGroupLabels': ['Mycophenolate Mofetil (MMF) Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75300', 'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'National Institute of Blood Diseases and Bone Marrow Transplantation', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'overallOfficials': [{'name': 'Rukh-e- Zainub, Pharm-D,Mphil(enrolled)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institute of Blood Diseases and Bone Marrow Transplantation'}, {'name': 'Shafaq Abdul Samad, MBBS,FCPS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National Institute of Blood Diseases and Bone Marrow Transplantation'}, {'name': 'Dr.Iyad Naeem, Ph.D', 'role': 'STUDY_CHAIR', 'affiliation': 'KARACHI UNIVERSITY'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Blood and Marrow Transplant (NIBMT), Pakistan', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}