Population Pharmacokinetics of Imatinib in CML Patients in Iran

September 2, 2016 updated by: Ehsan Mohajeri, Kerman University of Medical Sciences
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

170

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with approved diagnosis of chronic myeloid leukemia taking Imatinib as treatment

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Imatinib, CML
Patients with chronic myeloid leukemia who receive Imatinib as treatment in Iran entered in this study
Drug: Imatinib
Patients with chronic myeloid leukemia who receive Imatinib as treatment
Other Names:
  • Glivec

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of changes of AUC, trough Concentration from predicted values
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kerman University of Medical Sciences

Investigators

  • Study Director: ehsan mohajeri, Ph.D., Department of pharmaceutics, Faculty of pharmacy, Kerman University of medical sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

April 1, 2014

Study Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

April 9, 2014

First Submitted That Met QC Criteria

May 21, 2014

First Posted (Estimate)

May 26, 2014

Study Record Updates

Last Update Posted (Estimate)

September 7, 2016

Last Update Submitted That Met QC Criteria

September 2, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Kerman-001-FOPPT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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