Phase 2Recruiting

A Study of TAK-226 for Anemia in Japanese Patients With Lower-Risk Myelodysplastic Syndromes

A Phase 2, Multicenter, Open-Label, Single-arm Study to Evaluate the Efficacy and Safety of TAK-226 for Anemia in Japanese Patients With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes

Sponsor
Takeda (Industry)
Enrolment
42 planned
Conditions
Myelodysplastic Syndromes
Interventions
TAK-226
Ages
adults, older adults
Registry
NCT07319845

From the registry

The main aim of the study is to evaluate how TAK-226 improves symptoms of transfusion-dependent anemia in Japanese patients with lower-risk myelodysplastic syndromes. The study consists of Screening Period (up to 6 weeks), Treatment Period, Safety Follow-Up Period (8 weeks), and Long-Term Follow-Up Period (5 years from the first dose of the study drug or 3 years after the last dose, whichever is longer). Participants of this study will be administered TAK-226 during Treatment Period. Subsequently, the participants will be monitored for side effects related to the study treatment during Safety Follow-Up Period and Long-Term Follow-Up Period. The approximate duration of participation for a participant is up to approximately 6 years. During the study period, participants will visit the study clinic/hospital multiple times as per the study schedule. During Treatment Period, the participants will come to the clinic/hospital approximately every two to four weeks.

Primary outcomes

  • Transfusion dependent (TD) cohort: Percentage of Participants Achieving Transfusion Independence (TI) for Greater Than or Equal to (>=) 8 Weeks from Baseline through Week 24
  • Non-transfusion dependent (NTD) cohort: Percentage of Participants Achieving Mean Hgb Increase of >=1.5 grams per deciliter (g/dL) for >=8 Weeks from Baseline through Week 24 And No RBC Transfusion during the Same >=8 Weeks Period
Full record on ClinicalTrials.gov