Safety and Efficacy of Eculizumab in High-risk TA-TMA
Recruiting
Phase 2
Interventional Study
Transplant-Associated Thrombotic Microangiopathy (TA-TMA)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 24 (estimated)
- Sponsor
- First Affiliated Hospital of Zhejiang University · Other
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About This Trial
High-risk, complement-mediated, untreated transplant-associated thrombotic microangiopathy (hrTA-TMA) carries a very poor prognosis due to multiple organ dysfunction syndrome (MODS). The complement C5 inhibitor eculizumab has shown promising efficacy in children with hrTA-TMA, but has not been prospectively studied in adult allogeneic hematopoietic stem cell transplantation (HSCT) recipients. The …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Age ≥18 years.
* Patients who have undergone hematopoietic stem cell transplantation for any indication within 12 months prior to enrollment.
* Meet the diagnostic criteria for TA-TMA within ≤14 days prior to enrollment (at least 4 of the following 7 criteria present simultane…
Contacts