Efficacy and Safety Study of Narsoplimab in Pediatric Patients With High-Risk Hematopoietic Stem Cell Transplant TMA
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age28-17
SponsorOmeros Corporation
About this trial
The purpose of this study is to evaluate the safety and efficacy of narsoplimab in pediatric patients with thrombotic microangiopathies (TMA) following hematopoietic stem cell transplant (HSCT).
Eligibility criteria
Qualifiers
Age at least 28 days and less than 18 years prior to informed consent (Visit 0).
Have informed consent from at least one parent or legal guardian as required by local law and regulation. Patient informed consent will be required if the patient has reached the local legal age of majority.
Assent from patients as required by local law and regulation.
Have received an allogeneic hematopoietic stem cell transplant for the treatment of benign or malignant disease.
Disqualifiers
All treatments for HSCT-TMA are allowed except eculizumab, ravulizumab, and defibrotide within 3 months prior to informed consent, unless failure of therapy can be documented.
Have Shiga toxin-producing Escherichia coli haemolytic uraemic syndrome (STEC-HUS). Test results obtained within 28 days prior to informed consent may be used.
Have ADAMTS13 activity < 10%. Test results obtained within 28 days prior to informed consent may be used.
Have a severe, uncontrolled systemic bacterial or fungal infection requiring antimicrobial therapy, or a severe uncontrolled viral infection (as determined by the investigator); prophylactic antimicrobial therapy administered as standard of care is allowed.
Trial design
Treatments tested in this trial
- Biological: narsoplimab
Treatment groups
18 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov