Gladiolus Study

Gladiolus Study

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 If you are interested in participating in the study or want to learn more, please contact: Contact us
This study is now recruiting. Learn more about enrolling here.

Description

This Phase 2 clinicalresearch study is evaluating the safety and effectiveness of a once-daily oralinvestigational medicine that may improve anemia and reduce the need for redblood cell (RBC) transfusions among some patients who are chronicallytransfused. All participants enrolled in the study will receive theinvestigational medication.

We are currentlyenrolling individuals who meet the following criteria:*

  • Are 12 to 65 years of age
  • Have one of the following diagnoses:
    • SCD and receiving regularRBC transfusions to prevent stroke or recurrence of stroke (Cohort A)
    • Thalassemiaand receiving regular RBC transfusions (Cohort B)

    • Thalassemiaand not receiving regular RBC transfusions (Cohort C)


      Thereare additional eligibility requirements, which the investigator will explain toyou.

      Eligibility and criteria
      IRB Number:
      21-018910
      Eligible age range:
      12 years - 65 years
      Clinical trial phase:
      Phase II
      Official title:
      A Phase 2 Open-Label Study To Evaluate Safety And Clinical Activity Of FT-4202 In Patients With Thalassemia Or Sickle Cell Disease.

      What to expect

      Thetotal length of participation is up to 58 weeks, or just over one year. Duringthis time, participants will attend approximately 14 study visits over threeperiods: the screening period, the study treatment period, and an end-of-studyvisit four weeks after the last dose of the investigational medication. Each personwho qualifies will receive research study–related medical exams, laboratorytests, and the investigational medication at no cost.

      If the study medication improves your symptoms andanemia, you may qualify to participate in    an extensionof the study, in which you will receive the study drug for an additional year.
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      We need families like you

      Your time and participation make a difference in supporting the work of the Research Institute and children in our community. Learn more about opportunities to participate in our research.