A Study of TAK-226 for Anemia in Japanese Patients With Lower-Risk Myelodysplastic Syndromes
ConditionMyelodysplastic Syndromes
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTakeda
About this trial
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.
Eligibility criteria
Qualifiers
Participants or their legally authorized representative must be willing and able to sign the ICF and to adhere to the protocol requirements.
Japanese adult male or female participant >=18 years of age at the time of signing informed consent.
Diagnosis of MDS with or without ring sideroblasts (RS) (as determined in an evaluable bone marrow aspirate collected at Screening to confirm diagnosis) according to WHO 2016 classification that meets the International Prognostic Scoring System-Revised (IPSS-R) classification of very low-, low-, or intermediate-risk MDS.
Low-transfusion burden (LTB), defined as 4 to 7 RBC units per 16 weeks; or
Disqualifiers
Del(5q) MDS or therapy-related (secondary) MDS.
Anemia due to any other known cause (eg, thalassemia, hemolytic anemia, bleeding events, or deficiency of iron, B12, and/or folate).
Receipt of RBC transfusion for any reason(s) other than underlying MDS within 16 weeks in TD cohort or 8 weeks in NTD cohort before enrollment.
New York Heart Association heart disease class III or IV;
Trial design
Treatments tested in this trial
- TAK-226
Treatment groups
42 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov