Population Pharmacokinetics of Imatinib in CML Patients in Iran

NCT ID: NCT02146846

Last Updated: 2016-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

170 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2017-07-31

Brief Summary

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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.

Detailed Description

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

Conditions

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Chronic Myelogenous Leukemia

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Study Groups

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Imatinib, CML

Patients with chronic myeloid leukemia who receive Imatinib as treatment in Iran entered in this study

Imatinib

Intervention Type DRUG

Patients with chronic myeloid leukemia who receive Imatinib as treatment

Interventions

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Imatinib

Patients with chronic myeloid leukemia who receive Imatinib as treatment

Intervention Type DRUG

Other Intervention Names

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Glivec

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kerman University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Ehsan Mohajeri

Assistant of Pharmaceutics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ehsan mohajeri, Ph.D.

Role: STUDY_DIRECTOR

Department of pharmaceutics, Faculty of pharmacy, Kerman University of medical sciences

Locations

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Shahid-Bahonar hospital

Kerman, Kerman, Iran

Site Status

Countries

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Iran

Other Identifiers

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Kerman-001-FOPPT

Identifier Type: -

Identifier Source: org_study_id

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