Safety and Efficacy Study of OMS721 in Patients With Atypical Hemolytic Uremic Syndrome (NCT03205995) | Clinical Trial Compass
TerminatedPhase 3
Safety and Efficacy Study of OMS721 in Patients With Atypical Hemolytic Uremic Syndrome
Stopped: Sponsor terminated study
United States, Lithuania, Poland6 participantsStarted 2018-05-02
Plain-language summary
The purpose of this study is to evaluate the platelet count change from baseline and safety of OMS721 (narsoplimab) in adults and adolescents with atypical hemolytic uremic syndrome (aHUS). The study will also evaluate pharmacokinetics (PK), pharmacodynamics (PD), and anti-drug antibody response (ADA).
Who can participate
Age range12 Years
SexALL
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Inclusion criteria
✓. Are age \>= 12 years old at screening (Visit 1).
✓. Have a primary aHUS, diagnosed clinically, and have ADAMTS13 activity \> 5% in plasma. Participants are eligible with or without a documented complement mutation or anti-CFH antibody. Participants are categorized according to their response to plasma therapy (plasma exchange or plasma infusion):
✓. presence of schistocytes,
✓. serum LDH \> 1.5 times upper limit of normal (ULN), and
✓. haptoglobin \< LLN)
✓. If sexually active and of childbearing potential, must agree to practice a highly effective method of birth control until the end of the study, defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence or vasectomized partner.
✓. Do not have access to eculizumab treatment, have not derived therapeutic benefit from eculizumab treatment, or have not been able to tolerate eculizumab treatment.
Exclusion criteria
✕. Have STEC-HUS.
✕. Have a positive direct Coombs test.
✕. Have a history of hematopoietic stem cell transplant.
✕. Have HUS from an identified drug.
What they're measuring
1
Platelet Count (10^9 Platelets/L) Change From Baseline at Week 26