Extension Study, Pilot, Compassionate Use of Azacitidine 300 mg Film Coated Tablets for Acute Myeloid Leukaemia (AML) Patients
NCT06572982 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2026-01-14
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
Conditions
Interventions
- DRUG
-
300 mg Film coated tablets
Sponsors & Collaborators
-
Hikma Pharmaceuticals LLC
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-04-29
- Primary Completion
- 2026-05-31
- Completion
- 2026-05-31
Countries
- United Arab Emirates
Study Locations
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