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Tests treatment safety and results for Immune Thrombocytopenia
Official title Safety and Efficacy of GL-2045 in Patients With Immune Thrombocytopenia
ClinicalTrials.gov ID: NCT07605845
What this study is testing
What is GL-2045?
GL-2045 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for immune thrombocytopenia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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 people must have prior response to corticosteroids or to intravenous immunoglobin (IVIg) documented by a consultant hematologist. Prior...
- 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...
You likely can't join if
- 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.
- Any previous or current treatments prohibited by the protocol.
- Treatment within the last 4 weeks or intention to treat during the study with a thrombopoietin receptor agonist including romiplostim (Nplate®)...
The study team makes the final eligibility decision.
Where it's taking place
- Leeds, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leeds, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.