Status:
Recruiting
Disease Site:
Blood
Phase:
Phase I
Official Title:
A Multicenter, Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HMPL-523, a Syk Inhibitor, in Adult Subjects With Immune Thrombocytopenia
NCT ID:
NCT#06291415
Link to Full Details:
Description:
This is an open-label, multicenter study to evaluate the safety, tolerability, and efficacy of HMPL-523 in adult subjects with ITP.
Eligibility:
Male and Female – 18 years and older
Inclusion Criteria:
- Diagnosis of ITP, with a duration of disease of at least 3 months
- Intolerance or insufficient response or recurrence after at least 1 prior ITP treatment (excluding splenectomy)
- Response (defined as achieved a platelet count ≥50,000) to at least 1 prior ITP therapy (including splenectomy)
Exclusion Criteria:
- Clinically serious hemorrhage
- History of vital organ transplantation or hematopoietic stem-cell transplantation or chimeric antigen receptor T-cells (CAR-T) therapy
- Splenectomy within 12 weeks prior to enrollment
- History of serious cardiovascular disease corrected QT interval (QTcF) ≥450 ms