Acute Myeloid Leukemia
Conditions
Keywords
oral azacitidine, azacitidine, Acute Myeloid Leukaemia
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
Interventions
DRUGAzacitidine
300 mg Film coated tablets
Sponsors
Hikma Pharmaceuticals LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United Arab Emirates
Outcome results
None listed