Active — Not RecruitingNot Applicable

Extension Study, Pilot, Compassionate Use of Azacitidine 300 mg Film Coated Tablets for Acute Myeloid Leukaemia (AML) Patients

United Arab Emirates20 participantsStarted 2025-04-29

Plain-language 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 study with protocol number: HIK-AZA-2023-01

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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).

What they're measuring

Descriptive statistics for the type, frequency, severity, expectedness, seriousness, outcome and relationship of adverse events to study drug

Timeframe: Up to 12 months

Trial details

NCT IDNCT06572982

SponsorHikma Pharmaceuticals LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-05

View on ClinicalTrials.gov More Acute Myeloid Leukemia trials