A Study to Compare Elritercept With Epoetin Alfa to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions
Sponsored by Takeda
About this trial
Last updated a month ago
Study ID
TAK-226-3001
Status
Recruiting
Type
Interventional
Phase
Phase 3
Placebo
No
Accepting
18+ Years
All
Not accepting
Healthy Volunteers
Trial Timing
Started 4 days ago
What is this trial about?
The main aim of this study is to assess how elritercept works in lowering the need for
RBC (red blood cell) transfusions and how safe elritercept is when compared with epoetin
alfa. Other aims are to learn if elritercept improves tiredness as reported by
participants without needing RBC transfusion compared with epoetin alfa, the RBC
transfusion burden and quality of life compared with epoetin alfa. The study also aims to
find out the extent of the immune response to elritercept. The study will also check on
the medical problems (safety) of elritercept.
What are the participation requirements?
Inclusion Criteria
Men and women can participate in this study.
Must be 18 years.
Must have Lower-Risk Myelodysplastic Syndromes (LR-MDS). confirmed from bone marrow assessment by study pathologist
Must have symptoms of anemia requiring blood (red blood cells referred to as RBC) transfusions
Must not have received other treatment for: anemia, including ESA (for example epoetin alfa).
Exclusion Criteria
Cannot have received certain treatments.
Cannot have certain medical conditions.
Cannot need to take certain medications.
Additional entry criteria will be discussed with the study doctor.
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For more information, view the full study details:
NCT07422480