Single Arm, Companion Study to Myelodysplastic Syndrome (MDS) 20090160 Using Darbepoetin Alfa for the Treatment of Anaemic Subjects With Myelodysplastic Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment-emergent Adverse Events
研究概览
简要总结
The primary objective of the study was to provide required access of investigational product (darbepoetin alfa) beyond the end of the active treatment period (EOATP) of the darbepoetin alfa MDS 20090160 (NCT01362140) study for patients who had continued demonstration of benefit from darbepoetin alfa treatment and to describe the safety of longer-term use in this patient population.
详细描述
This is a phase 3b, multi-centre, open-label, single-arm companion study to the MDS 20090160 study (NCT01362140) for the treatment of anaemic patients with MDS. Participants who completed the active-treatment period of the darbepoetin alfa MDS 20090160 study and met the eligibility criteria could be enrolled into this study to continue treatment of darbepoetin alfa for up to 73 weeks or until progression to acute myelogenous leukemia (AML), whichever occurs first.
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
- •Subject or subject's legally acceptable representative has provided informed consent prior to any study-specific activities/ procedures being initiated;
- •Subject must continue long term follow up within parent study (20090160);
- •Subject must have an ongoing clinically relevant erythroid response as assessed by the Investigator using current response criteria (ie, International Working Group (IWG) response criteria);
排除标准
- •Transfusion dependence defined as receiving a total of ≥ 4 units of red blood cell (RBC) transfusion in the previous 8-week period prior to enrolment;
- •Known diagnosis of acute myelogenous leukemia (AML) or marrow collagen fibrosis;
- •Known refractory anaemia with excess blast-2 (RAEB-2);
- •Known diagnosis of intermediate-2 or high risk MDS per International Prognostic Scoring System (IPSS);
- •Subjects received thrombopoiesis-stimulating factors (eg, eltrombopag, romiplostim) in the MDS 20090160 study or planning to receive such agents during the study;
- •Other protocol defined inclusion and exclusion criteria may apply.
研究组 & 干预措施
Darbepoetin Alfa
Participants received darbepoetin alfa for up to 73 weeks or until progression to acute myeloid leukemia (AML), whichever occurred first.
干预措施: Darbepoetin Alfa (Drug)
结局指标
主要结局
Number of Participants With Treatment-emergent Adverse Events
时间窗: From first dose of darbepoetin alfa to 30 days after last dose; the maximum treatment duration was 73 weeks.
Adverse events (AEs) were graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, where Grade 1 indicates a mild AE, Grade 2 indicates a moderate AE, Grade 3 indicates severe or medically significant but not immediately life-threatening and Grade 4 indicates life-threatening consequences; urgent intervention indicated. A serious adverse event was defined as an adverse event that met at least one of the following serious criteria: * fatal * life threatening * required in-patient hospitalization or prolongation of existing hospitalization * resulted in persistent or significant disability/incapacity * congenital anomaly/birth defect * other medically important serious event The investigator assessed whether each adverse events was related to darbepoetin alfa.
次要结局
未报告次要终点