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NCT02146846 Clinical Trial

Population Pharmacokinetics of Imatinib in CML Patients in Iran

Chronic Myelogenous Leukemia Clinical Trial

Official title:
Population Pharmacokinetics of Imatinib in CML Patients in Iran

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02146846
Other study ID # Kerman-001-FOPPT
Secondary ID
Status Terminated
Phase N/A
First received April 9, 2014
Last updated September 2, 2016
Start date October 2012
Est. completion date July 2017

Study information
Verified date September 2016
Source Kerman University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: Ethics Committee
Study type Observational

Clinical Trial Summary

The purpose of this study is to determine population Pharmacokinetics and differences and variation of pharmacokinetics parameters of Imatinib as a tyrosine kinase inhibitor in treatment of chronic myeloid leukemia patients in Iranian population.

Description:

patients with chronic myeloid leukemia who receive Imatinib as treatment in Iran entered in this study then population pharmacokinetics parameters is determined.

Recruitment information / eligibility
Status Terminated
Enrollment 170
Est. completion date July 2017
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- patient in chronic phase of myeloid leukemia

- no liver and renal failure

Exclusion Criteria:

- multiple dug treatment

- previous treatment of interferon

- patients in blast or accelerated phase

Study Design

Observational Model: Ecologic or Community, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Imatinib
Patients with chronic myeloid leukemia who receive Imatinib as treatment

Locations
Country Name City State
Iran, Islamic Republic of Shahid-Bahonar hospital Kerman

Sponsors (1)
Lead Sponsor Collaborator
Kerman University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percent of changes of AUC, trough Concentration from predicted values The influence of patients' characteristic on the pharmacokinetics of Imatinib will be assessd. Blood sampling are collected on atleast the 30th day of treatment at the following time: 1 hour before the dose and 1 hour after the dose No
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