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TGD001 Treatment in Thrombotic Microangiopathies
EU CTIS ID: 2025-523802-34-00
What this study is testing
To assess the safety and tolerability of TGD001 in participants with suspicion or clinical diagnosis of an acute iTTP episode
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult: age ≥18 at the time of signing the informed consent form (ICF)
- Willing and able to provide informed consent and sign the ICF
- Male or female of childbearing potential must refrain from sexual intercourse or must use a contraceptive method that is highly effective (with a failure rate of <1% per year) during the trial and for at least 90 days after the last dose of trial drug
- Symptomatic acute TMA episode
- Patient accessible to follow-up
You likely can't join if
- Diagnosis other than TMA, which could account for the findings of thrombocytopenia and hemolytic anemia (e.g., disseminated intravascular coagulation [DIC], Evans syndrome)
- Pre-existing severe medical, neurological, or psychiatric disease that would significantly confound the endpoint evaluations (Investigator judgment)
- Known hypersensitivity to any of the trial treatments or their excipients or to drugs of similar chemical classes
- Participant participating in a trial involving an investigational drug or device within the last 30 days that would impact this trial
- Participants who cannot comply with trial protocol requirements and procedures
- Severe active infection indicated by sepsis (requirement for pressors with or without positive blood cultures)
See the full eligibility criteria
- Adult: age ≥18 at the time of signing the informed consent form (ICF)
- Willing and able to provide informed consent and sign the ICF
- Male or female of childbearing potential must refrain from sexual intercourse or must use a contraceptive method that is highly effective (with a failure rate of <1% per year) during the trial and for at least 90 days after the last dose of trial drug
- Symptomatic acute TMA episode
- Patient accessible to follow-up
- Diagnosis other than TMA, which could account for the findings of thrombocytopenia and hemolytic anemia (e.g., disseminated intravascular coagulation [DIC], Evans syndrome)
- Pre-existing severe medical, neurological, or psychiatric disease that would significantly confound the endpoint evaluations (Investigator judgment)
- Known hypersensitivity to any of the trial treatments or their excipients or to drugs of similar chemical classes
- Participant participating in a trial involving an investigational drug or device within the last 30 days that would impact this trial
- Participants who cannot comply with trial protocol requirements and procedures
- Severe active infection indicated by sepsis (requirement for pressors with or without positive blood cultures)
- Pregnant or breastfeeding
- History of bleeding diathesis or evidence of active abnormal bleeding within the previous 30 days
- Active internal bleeding
- Indication of symptomatic intracranial hemorrhage (sICH)
- Severe, uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg)
- Disseminated malignancy or other co-morbid illness limiting life expectancy <3 months independent of the TMA disorder
- Recent major surgery (Investigator judgment)
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- United States
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; United States. 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 EU CTIS; the study team decides eligibility.