Status:
COMPLETED
A Study Evaluating the Efficacy and Safety of ABP 959 Compared With Eculizumab in Adult Participants With PNH
Lead Sponsor:
Amgen
Conditions:
Paroxysmal Nocturnal Hemoglobinuria
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a randomized, double-blind, active-controlled phase 3 study of ABP 959 in participants with paroxysmal nocturnal hemoglobinuria.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 12 2022
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT03818607
Start Date
January 22 2019
End Date
July 12 2022
Last Update
May 23 2023
Active Locations (24)
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1
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, United States, 30322
2
Fakultní Nemocnice Brno
Brno, Jihormoravsky KRAJ, Czechia, 625 00
3
Fakultní Nemocnice Olomouc
Olomouc, Czechia, 772 00
4
Fakultní Nemocnice Ostrava
Ostrava-Poruba, Czechia, 708 52