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 range18 Years
SexALL
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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
What they're measuring
1
Incidence of treatment emergent adverse events (safety and tolerability of TGD001)