Extension Study, Pilot, Compassionate Use of Azacitidine 300 mg Film Coated Tablets for Acute Myeloid Leukaemia (AML) Patients
NCT ID: NCT06572982
Last Updated: 2026-01-14
Study Results
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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ACTIVE_NOT_RECRUITING
NA
20 participants
INTERVENTIONAL
2025-04-29
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Azacitidine 300 mg Film coated tablets
Azacitidine 300 mg Film coated tablets
Azacitidine
300 mg Film coated tablets
Interventions
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Azacitidine
300 mg Film coated tablets
Eligibility Criteria
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Inclusion Criteria
2. Patients who understand and voluntarily sign a written informed consent document prior to any study related assessment/procedures are conducted.
Exclusion Criteria
2. 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.
3. 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).
18 Years
ALL
No
Sponsors
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Hikma Pharmaceuticals LLC
INDUSTRY
Responsible Party
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Locations
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Sheikh Shakhbout Medical City
Abu Dhabi, , United Arab Emirates
Countries
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Other Identifiers
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HIK-AZA-2024-01
Identifier Type: -
Identifier Source: org_study_id
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