TGD001 Treatment in Thrombotic Microangiopathies
Key facts
- Where
- Valencia, SpainSee the site
- Phase
- Phase 1/2
Where in Spain
- La Fe University and Polytechnic HospitalValencia, SpainContact: Melinda SnyderTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- TargED Biopharmaceuticals B.V.
- Trial code
- NCT07459114
- Record updated
- 12 November 2026
- Original description
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.Read full original descriptionShow less
An Adaptive Dose Escalation and Expansion Basket Trial to Explore the Safety, Pharmacology, and Clinical Activity of TGD001 in Immune-Mediated Thrombotic Thrombocytopenic Purpura (iTTP) and Other Thrombotic Microangiopathies
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.
Inclusion: 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.
Exclusion: Received therapeutic plasma exchange (PEX) within 7 days prior to screening; Known bone marrow/graft failure; Diagnosis of ongoing severe, uncontrolled Graft versus Host Disease; 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; Diagnosis other than TMA, which could account for the findings of thrombocytopenia and hemolytic anemia; Diagnosis of Shiga-toxin induced HUS; Use of an anticoagulant and/or thrombolytics; Pregnant or breastfeeding.