NCT07605845 Safety and Efficacy of GL-2045 in Patients With Immune Thrombocytopenia
| NCT ID | NCT07605845 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Gliknik Inc. |
| Condition | Immune Thrombocytopenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2026-04-14 |
| Primary Completion | 2027-12-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 42 participants in total. It began in 2026-04-14 with a primary completion date of 2027-12-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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®).
Contact & Investigator
Jim Bush, MBChB, PhD
PRINCIPAL INVESTIGATOR
Fortrea Clinical Research Unit Ltd.
Frequently Asked Questions
Who can join the NCT07605845 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Immune Thrombocytopenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07605845 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07605845 currently recruiting?
Yes, NCT07605845 is actively recruiting participants. Contact the research team at gliknikclinicaltrialinquiries@gliknik.com for enrollment information.
Where is the NCT07605845 trial being conducted?
This trial is being conducted at Leeds, United Kingdom.
Who is sponsoring the NCT07605845 clinical trial?
NCT07605845 is sponsored by Gliknik Inc.. The principal investigator is Jim Bush, MBChB, PhD at Fortrea Clinical Research Unit Ltd.. The trial plans to enroll 42 participants.