NCT02175277

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2014

Typical duration for phase_3

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 12, 2014

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 24, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 26, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2017

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

October 11, 2018

Completed
Last Updated

November 14, 2018

Status Verified

October 1, 2018

Enrollment Period

2.8 years

First QC Date

June 24, 2014

Results QC Date

March 13, 2018

Last Update Submit

October 15, 2018

Conditions

Myelodysplastic Syndrome (MDS)

Keywords

Myelodysplastic Syndrome (MDS)Darbepoetin alfalow risk MDSintermediate-1 risk MDSInternational Prognostic Scoring System (IPSS)

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Treatment-emergent Adverse Events

    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.

    From first dose of darbepoetin alfa to 30 days after last dose; the maximum treatment duration was 73 weeks.

Study Arms (1)

Darbepoetin Alfa

EXPERIMENTAL

Participants received darbepoetin alfa for up to 73 weeks or until progression to acute myeloid leukemia (AML), whichever occurred first.

Drug: Darbepoetin Alfa

Interventions

Darbepoetin AlfaDRUG

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).

Also known as: Aranesp®
Darbepoetin Alfa

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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);

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Research Site

Charleroi, 6000, Belgium

Location

Research Site

Leuven, 3000, Belgium

Location

Research Site

Liège, 4000, Belgium

Location

Research Site

Sint-Niklaas, 9100, Belgium

Location

Related Links

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

Darbepoetin alfa

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesProteinsAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Study Director
Organization
Amgen Inc.
medinfo@amgen.com
866-572-6436

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2014

First Posted

June 26, 2014

Study Start

June 12, 2014

Primary Completion

March 20, 2017

Study Completion

March 20, 2017

Last Updated

November 14, 2018

Results First Posted

October 11, 2018

Record last verified: 2018-10

Locations

BE(4)