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

Not Applicable

Not yet recruiting

• Conditions: Acute Myeloid Leukemia
• Interventions: Drug: Azacitidine

• Registration Number: NCT06572982
• Lead Sponsor: Hikma Pharmaceuticals LLC

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-22
• Study First Submitted QC: 2024-08-25
• Study First Posted: 2024-08-27
• Last Update Submitted: 2025-03-23
• Last Update Posted: 2025-03-26
• Study Start: 2025-04
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Azacitidine 300 mg Film coated tablets	Azacitidine	Azacitidine 300 mg Film coated tablets

Primary Outcome Measures

Name	Time	Method
Descriptive statistics for the type, frequency, severity, expectedness, seriousness, outcome and relationship of adverse events to study drug	Up to 12 months	Descriptive statistics for the type, frequency, severity, expectedness, seriousness, outcome and relationship of adverse events to study drug