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

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-29

Study Completion Date

2026-05-31

Brief Summary

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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

Detailed Description

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Conditions

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Acute Myeloid Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Azacitidine 300 mg Film coated tablets

Azacitidine 300 mg Film coated tablets

Group Type EXPERIMENTAL

Azacitidine

Intervention Type DRUG

300 mg Film coated tablets

Interventions

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Azacitidine

300 mg Film coated tablets

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. 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.
2. Patients who understand and voluntarily sign a written informed consent document prior to any study related assessment/procedures are conducted.

Exclusion Criteria

1. Female patients who are pregnant or nursing (lactating).
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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hikma Pharmaceuticals LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sheikh Shakhbout Medical City

Abu Dhabi, , United Arab Emirates

Site Status

Countries

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United Arab Emirates

Other Identifiers

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HIK-AZA-2024-01

Identifier Type: -

Identifier Source: org_study_id

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