The goal of this clinical trial is to demonstrate GL-2045 safety and efficacy proof of concept by demonstrating intravenous immunoglobulin (IVig)-like platelet responses in adult patients with Immune Thrombocytopenia (ITP).
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Key Inclusion Criteria:
1. Male or female between 18 and 80 years of age with ITP or certain limited ITP conditions.
2. Females must not be pregnant or lactating. Males and females of childbearing potential must agree to use contraception.
3. A platelet count of 10 to 49 × 10\^9/L at baseline.
4. Study subjects must have prior response to corticosteroids or to intravenous immunoglobin (IVIg) documented by a consultant hematologist. Prior response to thrombopoietin receptor agonists is insufficient for eligibility.
5. The subject may be on a stable dose of corticosteroids for the 3 months prior to study entry, limited to a daily dose of prednisone 10 mg or equivalent. No reductions or increases of steroids are allowed during the study.
Key Exclusion Criteria:
1. Any serious adverse event (SAE) with prior IVIg dosing.
2. Prior splenectomy within 1 year of randomization or planned splenectomy during the study period.
3. Participants with grade 2 bleeding by World Health Organization (WHO) bleeding criteria in the 8 weeks prior to treatment.
4. Abnormal organ function including liver and kidney.
5. Any previous or current treatments prohibited by the protocol.
6. Treatment within the last 4 weeks or intention to treat during the study with a thrombopoietin receptor agonist including romiplostim (Nplate®), eltrombopag (Revolade®), or avatrombopag (Doptelet®).
Primary outcome measure(s)
Incidence, severity and type of adverse events and laboratory abnormalities — Screening (Days -28 to -2) to Follow-up (Day 55)
Multiple measurements of change from baseline in platelet count — Day -1 to Follow-up (Day 55)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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