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Study Complete
Sponsor ID
20130113

Darbepoetin alfa MDS companion protocol

Sponsor ID
20130113
Clinicaltrials.gov ID
NCT02175277
EUCTIS ID
N/A
EudraCT ID
2013-000727-13
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Study Details

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.

Additional Study Details

Phase
Phase 3
Product
darbepoetin alfa
Type
Interventional
Masking
None (Open Label)
Enrollment
9
Additional Study Details

Protocol Summary

Primary Outcome Measures

Subject incidence of treatment-emergent adverse events

Timeframe: up to 73 weeks

Secondary Outcome Measures

Disease progression to acute myeloid leukemia (AML)

Timeframe: up to 73 weeks

Mortality

Timeframe: up to 73 weeks

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
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Location
Research Site
Leuven, Belgium, 3000
Status
Recruiting
Location
Research Site
Charleroi, Belgium, 6000
Status
Recruiting
Location
Research Site
Sint-Niklaas, Belgium, 9100
Status
Recruiting
Location
Research Site
Liege, Belgium, 4000
Status
Recruiting
Study Info
Age
18+ years
Condition
  • Myelodysplastic Syndrome
    • Sex
    All
    Trial Dates
    Jun 2014 - Mar 2017
    Inclusion and Exclusion 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.