TGD001 Treatment in Thrombotic Microangiopathies (NCT07459114) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
TGD001 Treatment in Thrombotic Microangiopathies
70 participantsStarted 2026-05-31
Plain-language summary
This is a Phase 1/2, prospective, adaptive design trial of TGD001 in participants with suspicion or clinical diagnosis of acute immune thrombotic thrombocytopenic purpura (iTTP) episodes and participants with suspicion or clinical diagnosis of an acute Thrombotic Microangiopathy (TMA) episode. The trial is an open-label, dose escalation and expansion basket trial.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria:
* 18 years old or older
* Willing to sign an informed consent form
* Willing to refrain from sexual intercourse or must use a contraceptive method that is highly effective for 90 days after the last dose of TGD001
* Symptomatic acute TMA episode
* Accessible to follow-up
Key Exclusion Criteria:
* Diagnosis other than TMA, which could account for the findings of thrombocytopenia and hemolytic anemia
* Diagnosis of Shiga-toxin induced HUS
* Known bone marrow/graft failure
* Diagnosis of ongoing severe, uncontrolled Graft versus Host Disease
* Received therapeutic plasma exchange (PEX) within 7 days prior to screening
* Use of an anticoagulant and/or thrombolytics
* Active internal bleeding
* Any major bleeding episode within the past 30 days, or diagnosis of chronic bleeding conditions
* Known gastrointestinal ulcer
* Severe, uncontrolled hypertension, renal impairment requiring dialysis, or liver impairment, or active infection indicated by sepsis
* Life expectancy less than 3 months independent of TMA disorder
* Pregnant or breastfeeding
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of treatment emergent adverse events (safety and tolerability of TGD001)