Nomacopan (rVA576) in Transplant Associated Thrombotic Microangiopathy
Stopped early · Phase 3
Conditions studied: Thrombotic Microangiopathies
In brief
Multicentre Study of nomacopan in Paediatric Haematopoietic Stem-Cell Transplant Associated Thrombotic Microangiopathy
Key facts
- Study ID
- NCT04784455
- Run by
- AKARI Therapeutics
- People needed
- 10
- Starts
- 2021-02-01
- Expected to finish
- 2024-05-15
- Last updated by the study team
- 2025-06-05
Who can join
Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Aged ≥ 0.5 and < 18 years at the time of diagnosis of TMA.
- Undergone allogeneic or autologous HSCT.
- TMA diagnosis within a year of their allogeneic or autologous HSCT.
- Clinical or histological diagnosis of TMA
- Provision of written informed consent.
- Provision of informed assent
You may not qualify if…
- Patients weighing less than 5 kg.
- Patients with a positive direct Coombs' test.
- Patients who do not receive nomacopan within 21 days of the initial diagnosis of TMA.
- Patients having an active systemic or organ system bacterial or fungal infection or progressive severe infection at the time of diagnosis of TMA
- Grade 4 Acute graft-versus-host disease (GVHD)
- Received eculizumab or any other complement blocker therapy at any time.
- Known hypersensitivity to the active ingredient or excipients
- If an enrolled patient has a positive ADAMTS13 test (<10%) returned from their screening assessment, the patient should be withdrawn from the study
Where it is running
- Children's Hospital Los Angeles — Los Angeles, California, United States
- Stanford Children's Hospital — Palo Alto, California, United States
- Duke University Medical Center, Children's Health Center — Durham, North Carolina, United States
- Children's Hospitall of Philadelphia — Philadelphia, Pennsylvania, United States
- Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu — Wroclaw, Poland
- The Royal Marsden NHS Foundation Trust — London, United Kingdom
- St. Georges University Hospital — London, United Kingdom
- Great Ormond Street Hospital (GOSH) — London, United Kingdom
- Royal Manchester Children's Hospital — Manchester, United Kingdom
Full record on ClinicalTrials.gov
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