NCT06572982进行中（未招募）不适用
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Descriptive statistics for the type, frequency, severity, expectedness, seriousness, outcome and relationship of adverse events to study drug
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Azacitidine 300 mg Film coated tablets
Experimental
Azacitidine 300 mg Film coated tablets
干预措施: Azacitidine (Drug)
结局指标
主要结局
Descriptive statistics for the type, frequency, severity, expectedness, seriousness, outcome and relationship of adverse events to study drug
时间窗: Up to 12 months
Descriptive statistics for the type, frequency, severity, expectedness, seriousness, outcome and relationship of adverse events to study drug
次要结局
未报告次要终点
研究者
研究点 (1)
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