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

• Register: EUCTR
• Last refreshed on: 3 July 2017
• Main ID: EUCTR2013-000727-13-BE
• Date of registration: 23/08/2013
• Prospective Registration: Yes
• Primary sponsor: Amgen Inc
• Public title: Darbepoetin alfa in Anaemic Subjects With Low Risk Myelodysplastic Syndromes - Companion Study
• Scientific title: Single arm, Companion Study to Myelodysplastic Syndrome (MDS) 20090160 Using Darbepoetin alfa for the Treatment of Anaemic Subjects With Myelodysplastic Syndrome
• Date of first enrolment: 10/12/2013
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-000727-13
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Belgium

Contacts

• Name: IHQ Medical Info – Clinical Trials
• Affiliation: Amgen (EUROPE) GmbH

• Name: IHQ Medical Info – Clinical Trials
• Affiliation: Amgen (EUROPE) GmbH

Key inclusion & exclusion 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:
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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Intervention(s)

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
Concentration type: equal
Concentration number: 500-

Product Name: Darbepoetin alfa 300 µg
Pharmaceutical Form: Solution for injection
INN or Proposed INN: DARBEPOETIN ALFA
CAS Number: 209810-58-2
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 300-

Product Name: Darbepoetin alfa 200 µg
Pharmaceutical Form: Solution for injection
INN or Proposed INN: DARBEPOETIN ALFA
CAS Number: 209810-58-2
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 200-

Product Name: Darbepoetin alfa 100 µg
Pharmaceutical Form: Solution for injection
INN or Proposed INN: DARBEPOETIN ALFA
CAS Number: 209810-58-2
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Primary end point(s): Subject incidence of treatment-emergent adverse events

Secondary Objective: Not Applicable

Timepoint(s) of evaluation of this end point: No formal hypothesis will be tested. All study results will be descriptive

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 Outcome(s)

Secondary end point(s): Not Applicable

Timepoint(s) of evaluation of this end point: Not Applicable

Secondary ID(s)

20130113

Source(s) of Monetary Support

Amgen Inc