NCT03454503

Effectiveness and Safety Study of Generic Imatinib in Chronic Myeloid Leukemia Patients in Egypt

Evaluation of Generic Imatinib in a Real-World Setting Among Chronic Myeloid Leukemia Patients in Egypt

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 173 (actual)
• Sponsor: Hikma Pharmaceuticals LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this observational study is to evaluate the effectiveness and safety of generic imatinib under usual clinical practice in patients of Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) patients in chronic phase (CP) in Egypt

Detailed description

An observational, multi-center, prospective cohort study to assess the effectiveness and safety of generic Imatinib (Carcemia®) in patients with Ph+ CML who are newly diagnosed or patients who will be switched from the reference product (Glivec® ) to Carcemia® where treatment will be prescribed by the investigator in accordance with clinical practice where no visits or intervention(s) additional to the daily practice will be performed. Eligible Ph+ CML patients in both cohorts will be followed up for a total of 18 months.

Conditions

• Philadelphia Chromosome-positive Chronic Myeloid Leukemia in Chronic Phase

Interventions

Type	Name	Description
DRUG	Imatinib	Film coated tablet contains 400 mg imatinib (as mesilate)

Timeline

• Start date: 2018-05-13
• Primary completion: 2020-12-28
• Completion: 2020-12-28
• First posted: 2018-03-06
• Last updated: 2021-02-23

Locations

1 site across 1 country: Egypt