Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-31 @ 3:55 PM
Study NCT ID:
NCT04326933
Status:
UNKNOWN
Last Update Posted:
2022-02-22
First Post:
2019-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Tyrosine Kinase Inhibitors on Liver Enzymes and Electrolytes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000092004', 'term': 'Tyrosine Kinase Inhibitors'}, {'id': 'D000068877', 'term': 'Imatinib Mesylate'}, {'id': 'C498826', 'term': 'nilotinib'}], 'ancestors': [{'id': 'D047428', 'term': 'Protein Kinase Inhibitors'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-19', 'studyFirstSubmitDate': '2019-11-21', 'studyFirstSubmitQcDate': '2020-03-27', 'lastUpdatePostDateStruct': {'date': '2022-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Follow up liver enzymes as AST, ALT, ALP and GGT before starting treatment and during the period of treatment by Tyrosine Kinase Inhibitors (Imatinib & Nilotinib).', 'timeFrame': '6 months', 'description': 'Changes happen in liver enzymes after a period of treatment by Tyrosine Kinase Inhibitors (Imatinib \\& Nilotinib) which are assessed by measuring liver enzymes as AST, ALT, ALP, GGT before starting treatment and during the period of treatment and the relation between these changes and the hematologic response to the treatment that is assessed by CBC and BCR-ABL Gene.'}, {'measure': 'Follow up electrolytes as Na, K, Ca and P before starting treatment and during the period of treatment by Tyrosine Kinase Inhibitors (Imatinib & Nilotinib)', 'timeFrame': '6 months', 'description': 'Changes happen in electrolytes after a period of treatment by Tyrosine Kinase Inhibitors (Imatinib \\& Nilotinib) which are assessed by measuring electrolytes levels before starting treatment and during the period of treatment and the relation between these changes and the hematologic response to the treatment that is assessed by CBC and BCR-ABL Gene'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Patients Diagnosed as Chronic Meyloid Leukemia']}, 'descriptionModule': {'briefSummary': 'Determine the effects of tyrosine kinase Inhibitors on liver enzymes and electrolytes in relation to hematologic response in patients with chronic phase chronic meyloid leukemia.. Assiut University Hospital insight..', 'detailedDescription': 'CML is a myeloproliferative neoplasm with unique biological and clinical features.\n\nCML accounts for 15\\_20% of newly diagnosed cases of leukemias among adults. CML can present in three clinical phases : chronic phase, accelerated phase and blast phase.\n\nCML is characterized by prodction of a breakpoint cluster region abelson(BCR-ABL) fusion protein with ABL kinase activity. This is due to reciprocal translocation between chromosome 9 and 22.\n\nImatinib \\& Nilotinib, an ABL kinase inhibitors, which has revolutionized the CML therapy, are a selective tyrosine kinase inhibitors.\n\nThe aim of the study is to determine the changes of liver enzymes and electrolytes in relation to hematologic response during treatment period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Newly diagnosed patients with chronic phase chronic meyloid leukemia.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed patients with CML\n* Chronic phase CML\n* Normal hepatic and renal functions\n\nExclusion Criteria:\n\n* Blastic phase CML\n* Accelerated phase CML\n* Hepatic \\& renal impairment'}, 'identificationModule': {'nctId': 'NCT04326933', 'briefTitle': 'Effects of Tyrosine Kinase Inhibitors on Liver Enzymes and Electrolytes', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Effects of Tyrosine Kinase Inhibitors on Liver Enzymes and Electrolytes in Relation to Hematologic Response in Patients With Chronic Phase Chronic Meyloid Leukemia: Assiut University Hospital Insight', 'orgStudyIdInfo': {'id': 'TKI In CML'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Tyrosine kinase Inhibitors (Imatinib & Nilotinib)', 'type': 'DRUG', 'otherNames': ['Glivic & Tasigna'], 'description': 'Administration of tyrosine kinase inhibitors (Imatinib in a dose of 400mg/day \\& Nilotinib in adose of 600mg/day)'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assiut University Hospital', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'Howaida A Nafady, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Not affiliated'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Noha Mahmoud', 'investigatorAffiliation': 'Assiut University'}}}}