Single arm, Companion Study to Myelodysplastic Syndrome (MDS)20090160 Using Darbepoetin alfa for the Treatment of Anaemic Subjects With Myelodysplastic Syndrome

Amgen Inc0 个研究点开始时间: 2013年8月23日最近更新: 2017年7月3日

适应症

试验速览

暂无简介。

•- Subject or subject’s legally acceptable representative has provided informed consent prior to any study-specific activities/procedures being initiated;
•- Subject must continue LTFU within parent study (20090160)
•- Subject understands that darbepoetin alfa treatment will not be provided by Amgen past week 73;
•Disease-related
•- Subject completes dosing in the active treatment period (through week 70 or week 71) and completed the end of the active treatment period (EOATP) visit of the parent study (20090160);
•- Subject must have an ongoing clinically relevant erythroid response as assessed by the Investigator using current response criteria (ie, IWG response criteria);
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 2
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 8

•Disease-related
•- Transfusion dependence defined as receiving a total of = 4 units of 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 IPSS;
•Medications or Other Treatments
•- Subjects received thrombopoiesis-stimulating factors (eg, eltrombopag, romiplostim) in the MDS 20090160 study or planning to receive such agents during the study;
•- Subjects receiving any investigational agents/devices not currently approved by the country’s regulatory authority for the indication of use.

发起方