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NCT Number: NCT06572982

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sheikh Shakhbout Medical City

Abu Dhabi, United Arab Emirates

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Azacitidine

Drug

300 mg Film coated tablets

Primary outcomes

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

    Time frame: Up to 12 months

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

Sponsors and collaborators

Lead sponsor

Hikma Pharmaceuticals LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 27, 2024
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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