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Recruiting Phase 3 2025-523544-12-00

A Phase 3, Multicenter, Open-Label, Randomized Trial to Compare the Efficacy and Safety of Elritercept versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes in ESA-naïve Adult Participants Who Require Red Blood Cell Transfusions

Phase 3 – large-scale trial before approval
Conditions: Myelodysplastic neoplasms/syndromes (MDS)

Sponsor: Takeda Development Center Americas Inc.

trial.available_in: БГ
Overview
Trial status: Authorised Key Secondary Endpoint: Proportion of participants who are RBC-TI for any consecutive ≥16-week period from C1D1 through Week 24., Key Secondary Endpoint: Proportion of participants who are RBC-TI for any consecutive ≥12-week period from C1D1 through Week 24., Key Secondary Endpoint: Proportion of participants who are RBC-TI for a consecutive 24-week period from C1D1., For further details please refer to the Protocol Proportion of participants who are RBC-TI for any consecutive ≥12-week period from Cycle 1 Day 1 (C1D1) through Week 24 with concurrent mean Hgb increase ≥1.5 g/dL from baseline
Description
Key Secondary Endpoint: Proportion of participants who are RBC-TI for any consecutive ≥16-week period from C1D1 through Week 24., Key Secondary Endpoint: Proportion of participants who are RBC-TI for any consecutive ≥12-week period from C1D1 through Week 24., Key Secondary Endpoint: Proportion of participants who are RBC-TI for a consecutive 24-week period from C1D1., For further details please refer to the Protocol
Who can participate
Age group: 65+ years, 18-64 years Gender: Female, Male Target enrollment: 51 participants
Interventions
ERYTHROPOIETIN
Drug
Elritercept
Drug
Locations 6
Belgium (1)
Greece (1)
Lithuania (1)
Netherlands (1)
Norway (1)
Spain (1)
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
17.04.2026
Registry ID
2025-523544-12-00
Source
euclinicaltrials.eu
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