Myelodysplastic Syndrome Clinical Trial
A Study Evaluating the Efficacy and Safety of ABP 959 Compared With Eculizumab in Adult Participants With PNH
This is a randomized, double-blind, active-controlled phase 3 study of ABP 959 in participants with paroxysmal nocturnal hemoglobinuria.
Men and women ≥ 18 years of age.
Historical diagnosis of PNH.
Administration of eculizumab for ≥ 6 months and currently receiving 900 mg of eculizumab.
Hemoglobin ≥ 9.0 g/dL for at least 6 weeks before randomization.
Lactate dehydrogenase < 1.5 × the upper limit of normal at screening.
Platelet count ≥ 50 × 10^9/L.
Absolute neutrophil count (ANC) ≥ 0.5 x 10^9/L (500/μL).
Participants must be vaccinated against Neisseria meningitidis.
Participants must sign an IRB/IEC-approved ICF before participation in any procedures.
Known or suspected hereditary complement deficiency.
Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure [New York Heart Association ≥ Class III], serious uncontrolled cardiac arrhythmia), peripheral vascular disease, cerebrovascular accident, or transient ischemic attack in the previous 6 months.
Evidence of acute thrombosis (liver Doppler ultrasound of hepatic and portal veins).
Known to be positive for human immunodeficiency virus.
Woman who is pregnant or breastfeeding.
Participant is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or participant is receiving other investigational agent(s).
Participant has known sensitivity to any of the products to be administered during the study, including mammalian cell-derived drug products.
History of meningococcal infection.
Presence or suspicion of active bacterial infection, or recurrent bacterial infection.
History of bone marrow transplantation.
Red blood cell transfusion required within 12 weeks before randomization.
Participant experienced ≥ 2 breakthrough events, (ie, signs and symptoms of intravascular hemolysis, that require dose and/or schedule adjustments of eculizumab) in the previous 12 months before screening.
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There are 24 Locations for this study
Atlanta Georgia, 30322, United States
Brno Jihormoravsky KRAJ, 625 0, Czechia
Olomouc , 772 0, Czechia
Ostrava-Poruba , 708 5, Czechia
Jyväskylä , FI-40, Finland
Lahti , FI-15, Finland
Cesson-Sevigne Bretagne, 35576, France
Dublin , 8, Ireland
Meldola Forli-cesena, 47014, Italy
Monza Monza Brianza, 20052, Italy
Cuneo , 12100, Italy
Ravenna , 48121, Italy
Roma , 00168, Italy
Nijmegen Gelderland, 6525 , Netherlands
Oslo , 0372, Norway
Porto , 4200-, Portugal
Ljubljana , 1000, Slovenia
Salamanca , 37007, Spain
Valencia , 46026, Spain
Stockholm , 141 8, Sweden
Bornova Izmir, 35100, Turkey
Mersin , 33110, Turkey
Leeds England, LS9 7, United Kingdom
London England, SE5 9, United Kingdom
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