Status:
NOT_YET_RECRUITING
Extension Study, Pilot, Compassionate Use of Azacitidine 300 Mg Film Coated Tablets for Acute Myeloid Leukaemia (AML) Patients
Lead Sponsor:
Hikma Pharmaceuticals LLC
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Extension study, pilot, single-arm, compassionate use of Hikma Azacitidine 300 mg Film coated tablets test product for the Acute Myeloid Leukaemia (AML) patients who completed Hikma bioequivalence stu...
Eligibility Criteria
Inclusion
- Patients with AML who completed Hikma bioequivalence study of the same Hikma generic oral Azacitidine test product with protocol number: HIK-AZA-2023-01, and who consent to participate in the study.
- Patients who understand and voluntarily sign a written informed consent document prior to any study related assessment/procedures are conducted.
Exclusion
- Female patients who are pregnant or nursing (lactating).
- Patients with medical condition, laboratory abnormality, or psychiatric illness that, in the opinion of the investigator, might interfere with subject safety, compliance or evaluation of the condition of the study.
- Patients with experience in any investigational drug in a clinical study within 6 months prior to study (except for patients who were enrolled in the Hikma Azacitidine bioequivalence study with protocol number: HIK-AZA-2023-01).
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06572982
Start Date
April 1 2025
End Date
May 1 2026
Last Update
March 26 2025
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