drugset / Trial / NCT05927012
A Study to Evaluate the Safety and Preliminary Efficacy of a Response-guided Dose Titration of KER-047 in the Treatment of Functional IDA (Iron Deficiency Anemia).
Non-randomizedSequentialOpen-labelTreatment
Summary
This study aims to explore the safety and preliminary efficacy of a response-guided dose titration of KER-047 in the treatment of functional IDA (Iron deficiency anemia) in MDS (Myelodysplastic syndrome), MF(Myelofibrosis), and MDS/MPN (Myeloproliferative neoplasm) overlap syndromes.
Timeline
- Start
- 2023-11-30
- Primary completion
- 2025-08-29
- Completion
- 2026-01-04
Outcome
Outcome not reported
Stopped (Enrollment): “Despite several attempts to recruit eligible participants and major protocol amendments to increase the recruitment rate, recruitment challenges remained. Therefore, the Sponsor has made the decision to terminate the KER047-IR-202 Study globally.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | KER-047 | Small molecule | 30 mg | Oral |
| Subject | KER-047 | Small molecule | 60 mg | Oral |
| Subject | KER-047 | Small molecule | 80 mg | Oral |