The Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HMPL-523 in Adult Subjects With Immune Thrombocytopenia (ITP)

Launched by HUTCHMED · Feb 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called HMPL-523 for adults with a condition known as Immune Thrombocytopenia (ITP). ITP is a blood disorder where the body doesn't have enough platelets, which are important for blood clotting. The main goals of the study are to assess how safe HMPL-523 is, how well people tolerate it, and if it can effectively raise platelet counts in those who haven't responded well to previous treatments.

To be eligible for this trial, participants must be at least 18 years old and have been diagnosed with ITP for at least three months. They should have tried at least one previous ITP treatment that didn't work well for them. However, certain people, such as those with other serious health issues or recent surgeries, may not qualify. If you join the study, you will receive the treatment and be monitored closely to evaluate its effects on your platelet levels and overall health. This trial is currently recruiting participants, so if you or someone you know is living with ITP, it may be worth considering.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Subjects may be enrolled in this study only if they satisfy all the following criteria:
• • 1. Adult male or female subjects ≥18 years of age
• • 2. Diagnosis of ITP, with a duration of disease of at least 3 months prior to randomization or enrollment
• • 3. Intolerance or insufficient response or recurrence after at least 1 prior ITP treatment (excluding splenectomy)
• • 4. Response (defined as achieved a platelet count ≥50 × 109/L) to at least 1 prior ITP therapy (including splenectomy)
• • 5. Adequate hematologic, hepatic and renal function
• Exclusion Criteria:
• Subjects are not eligible for enrollment into this study if any one of the following criteria are met:
• • 1. Evidence of the presence of secondary causes of ITP
• • 2. Clinically serious hemorrhage requiring immediate adjustment of platelets
• • 3. Known history of vital organ transplantation or hematopoietic stem-cell transplantation or chimeric antigen receptor T-cells (CAR-T) therapy
• • 4. Splenectomy within 12 weeks prior to enrollment
• • 5. Presence of active malignancy unless deemed cured by adequate treatment.
• • 6. History of serious cardiovascular disease corrected QT interval (QTcF) ≥450 ms
• • 7. Uncontrolled hypertension
• • 8. Being unsuitable to participate in this study as considered by investigators