Safety and Efficacy of GL-2045 in Patients With Immune Thrombocytopenia
ConditionImmune Thrombocytopenia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorGliknik Inc.
About this trial
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 criteria
Qualifiers
Male or female between 18 and 80 years of age with ITP or certain limited ITP conditions.
Females must not be pregnant or lactating. Males and females of childbearing potential must agree to use contraception.
A platelet count of 10 to 49 × 10^9/L at baseline.
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.
Disqualifiers
Any serious adverse event (SAE) with prior IVIg dosing.
Prior splenectomy within 1 year of randomization or planned splenectomy during the study period.
Participants with grade 2 bleeding by World Health Organization (WHO) bleeding criteria in the 8 weeks prior to treatment.
Abnormal organ function including liver and kidney.
Trial design
Treatments tested in this trial
- GL-2045
Treatment groups
42 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov