Effects of Tyrosine Kinase Inhibitors on Liver Enzymes and Electrolytes
NCT ID: NCT04326933
Last Updated: 2022-02-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
40 participants
OBSERVATIONAL
2020-01-01
2022-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of TMC207 in Patients With Moderately Impaired Hepatic Function
NCT01012284
Pharmacokinetics and Safety of SHR0302 in Patients With Hepatic Impairment
NCT04293029
Liver Function Test (LFT) Elevations in Cancer Patients and Users of Tyrosine Kinase Inhibitor (TKI) Drugs
NCT01098500
Pharmacokinetic Study of Icenticaftor in Participants With Hepatic Impairment
NCT04587622
A Study to Assess Pharmacokinetics of Preladenant in Participants With Chronic Hepatic Impairment (P06513)
NCT01465412
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
CML 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.
CML 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.
Imatinib \& Nilotinib, an ABL kinase inhibitors, which has revolutionized the CML therapy, are a selective tyrosine kinase inhibitors.
The aim of the study is to determine the changes of liver enzymes and electrolytes in relation to hematologic response during treatment period.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Tyrosine kinase Inhibitors (Imatinib & Nilotinib)
Administration of tyrosine kinase inhibitors (Imatinib in a dose of 400mg/day \& Nilotinib in adose of 600mg/day)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Chronic phase CML
* Normal hepatic and renal functions
Exclusion Criteria
* Accelerated phase CML
* Hepatic \& renal impairment
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Assiut University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Noha Mahmoud
Principal investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Howaida A Nafady, Prof.
Role: PRINCIPAL_INVESTIGATOR
Not affiliated
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Assiut University Hospital
Asyut, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TKI In CML
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.