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Darbepoetin Alfa MDS Companion Protocol

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ClinicalTrials.gov Identifier: NCT02175277
Recruitment Status : Completed
First Posted : June 26, 2014
Results First Posted : October 11, 2018
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Myelodysplastic Syndrome (MDS) Drug: Darbepoetin Alfa Phase 3

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Arm, Companion Study to Myelodysplastic Syndrome (MDS) 20090160 Using Darbepoetin Alfa for the Treatment of Anaemic Subjects With Myelodysplastic Syndrome
Actual Study Start Date : June 12, 2014
Actual Primary Completion Date : March 20, 2017
Actual Study Completion Date : March 20, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Darbepoetin Alfa
Participants received darbepoetin alfa for up to 73 weeks or until progression to acute myeloid leukemia (AML), whichever occurred first.
Drug: Darbepoetin Alfa
The first dose of darbepoetin alfa was the same as that administered at the last dosing visit of the active treatment period in Study 20090160. Doses could be increased up to a maximum of 500 μg every two weeks (Q2W).
Other Name: Aranesp®




Primary Outcome Measures :
  1. Number of Participants With Treatment-emergent Adverse Events [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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);

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02175277


Locations
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Belgium
Research Site
Charleroi, Belgium, 6000
Research Site
Leuven, Belgium, 3000
Research Site
Liege, Belgium, 4000
Research Site
Sint-Niklaas, Belgium, 9100
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
  Study Documents (Full-Text)

Documents provided by Amgen:
Statistical Analysis Plan  [PDF] June 12, 2014
Study Protocol  [PDF] April 15, 2013

Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02175277    
Other Study ID Numbers: 20130113
2013-000727-13 ( EudraCT Number )
First Posted: June 26, 2014    Key Record Dates
Results First Posted: October 11, 2018
Last Update Posted: November 14, 2018
Last Verified: October 2018
Keywords provided by Amgen:
Myelodysplastic Syndrome (MDS)
Darbepoetin alfa
low risk MDS
intermediate-1 risk MDS
International Prognostic Scoring System (IPSS)
Additional relevant MeSH terms:
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Preleukemia
Myelodysplastic Syndromes
Syndrome
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Darbepoetin alfa
Hematinics