Table of Contents
- Trial overview
- Acute ischemic stroke study
- Thrombotic microangiopathy study
- Who can participate
- What the trials measure
- Trial phase and study design
Trial overview
Two authorized interventional trials are studying UROKINASE, CATALYTIC DOMAIN, FUSED WITH A SINGLE-CHAIN ANTIBODY AGAINST VON WILLEBRAND FACTOR.[1][2] Both are Phase 1 studies, which are early trials mainly designed to look at safety and tolerability.[1][2]
Acute ischemic stroke study
The first trial is titled “Evaluation of Novel Thrombolytic TGD001 in Patients With Acute Ischemic Stroke” and is being done in people with acute ischemic stroke.[1] The study is authorized, planned for 130 participants, and is given as an interventional study with intravenous treatment.[1]
This study includes people whose stroke is supported by neuroimaging, meaning brain scans are used to confirm the diagnosis.[1] It includes two groups: people who receive endovascular thrombectomy and people who do not receive endovascular thrombectomy or standard-of-care intravenous thrombolysis.[1]
The main goal is to assess the safety and tolerability of single intravenous doses of TGD001 in this stroke setting.[1] The primary outcomes are symptomatic intracranial hemorrhage and treatment-emergent adverse events.[1]
Thrombotic microangiopathy study
The second trial is titled “TGD001 Treatment in Thrombotic Microangiopathies” and is also authorized and interventional.[2] It studies people with immune-mediated thrombotic thrombocytopenic purpura and thrombotic microangiopathy.[2]
This trial plans to enroll 70 participants and is focused on an acute episode, meaning a sudden active phase of illness.[2] The brief summary says the study aims to assess the safety and tolerability of TGD001 in participants with suspicion or clinical diagnosis of an acute iTTP episode.[2]
The primary outcome in this study is treatment-emergent adverse events.[2] That means the researchers are watching for health problems that appear after treatment begins.[2]
Who can participate
In the stroke trial, participants must have acute ischemic stroke and the diagnosis must be supported by imaging.[1] The trial also separates participants based on whether they receive endovascular thrombectomy or not.[1]
In the thrombotic microangiopathy trial, participants are people with suspicion or a clinical diagnosis of an acute immune-mediated thrombotic thrombocytopenic purpura episode.[2] The condition list also includes thrombotic microangiopathy, showing that the study is focused on this disease group.[2]
What the trials measure
The stroke trial uses two main endpoints, or main results the study wants to measure: symptomatic intracranial hemorrhage and treatment-emergent adverse events.[1] These endpoints help researchers check both serious bleeding and overall safety.[1]
The thrombotic microangiopathy trial uses treatment-emergent adverse events as its primary endpoint.[2] This endpoint is a standard way to track whether new health problems happen after treatment starts.[2]
Trial phase and study design
Both studies are in Phase 1, which is usually the first stage of testing in people.[1][2] At this stage, the main focus is safety, tolerability, and early signs of how the treatment behaves in the target group.[1][2]
Both trials are listed as interventional, meaning the researchers give a treatment and then observe the results.[1][2] Together, the two studies plan to enroll 200 people.[1][2]
