NCT06572982Active, not recruiting
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
Source: ClinicalTrials.gov · Last updated 14 Jan 2026
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 22 Aug 2024
- Start date
- 29 Apr 2025
- Primary completion date
- May 2026
- Lead sponsor
- Hikma Pharmaceuticals LLC
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT06572982
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 29 Apr 2025 to the primary completion date, May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Lab values
- 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.
Other
- Female patients who are pregnant or nursing (lactating).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sheikh Shakhbout Medical City Coordinator of this site? Confirm its status | Abu Dhabi | United Arab Emirates | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.