Darbepoetin alfa in Anaemic Subjects With Low Risk Myelodysplastic Syndromes - Companion Study

Phase 1

Conditions: ow or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
MedDRA version: 16.0Level: HLTClassification code 10028536Term: Myelodysplastic syndromesSystem Organ Class: 100000004851
Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Registration Number: EUCTR2013-000727-13-BE

Lead Sponsor: Amgen Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

General
- 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

Exclusion Criteria

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To provide required access of investigational product (darbepoetin alfa) beyond the end of active treatment period of the Darbepoetin alfa MDS 20090160 study for subjects that have continued demonstration of benefit from darbepoetin alfa treatment and to describe the safety of longer-term use in this patient population.;Secondary Objective: Not Applicable;Primary end point(s): Subject incidence of treatment-emergent adverse events;Timepoint(s) of evaluation of this end point: No formal hypothesis will be tested. All study results will be descriptive

Secondary Outcome Measures