Nomacopan (rVA576) in Transplant Associated Thrombotic Microangiopathy

  • STATUS
    Recruiting
  • End date
    Jun 14, 2024
  • participants needed
    50
  • sponsor
    AKARI Therapeutics
Updated on 14 March 2021

Summary

Multicentre Study of nomacopan in Paediatric Haematopoietic Stem-Cell Transplant Associated Thrombotic Microangiopathy

Description

This is an open-label, multi-centre study of two-parts, Part A and B, includes 24 weeks of treatment, safety follow up after 30 days.

Part A: dose algorithm, safety and efficacy

Part B: safety and efficacy

Details
Condition Thrombotic microangiopathy, Thrombocytopenia, Thrombocytopenia and Thrombocytopenia Prevention
Treatment nomacopan (rVA576)
Clinical Study IdentifierNCT04784455
SponsorAKARI Therapeutics
Last Modified on14 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Aged 0.5 and < 18 years at the time of diagnosis of TMA
Undergone allogeneic or autologous HSCT
TMA diagnosis within 100 days of their first allogeneic or autologous HSCT
Clinical or histological diagnosis of TMA
Provision of written informed consent
Provision of informed assent

Exclusion Criteria

Patients weighing less than 5 kg
Patients with a positive direct Coomb's test
Patients who do not receive nomacopan within 14 days of the initial diagnosis of TMA
Patients having an active systemic or organ system bacterial or fungal infection or progressive severe infection
Grade 4 Acute GVHD
Received eculizumab or any other complement blocker therapy at any time
Known hypersensitivity to the active ingredient or excipients
A positive ADAMTS13 test (<10%)
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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