MDS Clinical Trial
Official title:
A Multicenter, Randomised, Double-blind, Placebo-controlled Study of Darbepoetin Alfa for the Treatment of Anaemic Subjects With Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
The primary objective was to assess the superiority of darbepoetin alfa versus placebo on the incidence of red blood cell transfusions during the 24-week double-blind treatment period in anemic patients with low or intermediate-1 risk MDS.
This study consists of a 3-week screening period, a 24-week double-blind treatment period,
and a 48-week active treatment period and the long-term follow-up period.
An end of treatment period (EOTP) visit occurs at week 25, or 3 weeks after last dose of
investigational product (IP) for participants who withdraw from the study. After entering the
active treatment period, an end of active treatment period (EOATP) visit occurs at week 72 /
73, or 3 weeks after the last dose of darbepoetin alfa.
Long-term follow-up (LTFU) will occur every 26 weeks (± 4 weeks) from the EOATP visit (or
EOTP visit if the participant does not enter the active treatment period) and will continue
for a minimum of 3 years from the first dose of IP. Follow-up may occur through clinic visit
or telephone contacts. Information on the participant's survival and progression to AML
status will be collected during LTFU.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
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