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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-000727-13-BE

Enrollment

Unknown

Registered

2013-08-23

Start date

2013-12-10

Completion date

Unknown

Last updated

2017-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) MedDRA version: 16.0 Level: HLT Classification code 10028536 Term: Myelodysplastic syndromes System Organ Class: 100000004851

Interventions

Product Name: Darbepoetin alfa 500 µg Pharmaceutical Form: Solution for injection INN or Proposed INN: DARBEPOETIN ALFA CAS Number: 209810-58-2 Concentration unit: µg/ml microgram(s)/millilitre Concen

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
Secondary end point(s): Not Applicable;Timepoint(s) of evaluation of this end point: Not Applicable	—

Countries

Belgium

Contacts

Public ContactIHQ Medical Info – Clinical Trials

Amgen (EUROPE) GmbH

MedinfoInternational@amgen.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026