Health Trials

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 group

Locations

16
Germany
Omeros Investigational Site Halle Germany
Omeros Investigational Site Hanover Germany
Israel
Omeros Investigational Site Haifa Israel
Omeros Investigational Site Jerusalem Israel

Sponsors and collaborators

Omeros Corporation

Lead sponsor

Source ClinicalTrials.gov