Study Complete
Sponsor ID
20150168
A Study Evaluating the Efficacy and Safety of ABP 959 Compared With Eculizumab in Adult Participants With PNHDAHLIA
Study Details
This is a randomized, double-blind, active-controlled phase 3 study of ABP 959 in participants with paroxysmal nocturnal hemoglobinuria.
Protocol Summary
Primary Outcome Measures
Hemolysis as measured by Lactate dehydrogenas (LDH) (Parallel Comparison)
Timeframe: 12 months
Hemolysis as measured by LDH (Crossover Comparison)
Timeframe: 18 months
Secondary Outcome Measures
Total hemolytic complement (Total Complement)
Timeframe: 18 months
Total hemoglobin
Timeframe: 18 months
Serum-free hemoglobin
Timeframe: 18 months
Haptoglobin
Timeframe: 18 months
Bilirubin
Timeframe: 18 months
Degree of hemoglobinuria
Timeframe: 18 months
Type III erythrocytes
Timeframe: 18 months
Crossover comparison of hemolysis as measured by LDH
Timeframe: 18 months
Lactate dehydrogenase-time profile
Timeframe: 18 months
Incidence of red blood cell transfusion
Timeframe: 18 months
Pharmacokinetic area under the curve (AUC) of ABP 959
Timeframe: 18 months
Pharmacokinetic area under the curve (AUC) of eculizumab
Timeframe: 18 months
Locations
Location
Azienda USL della Romagna
Ravenna, RAVENNA, Italy, 48121
Status
Recruiting
Location
Radboud Universitair Medisch Centrum
Nijmegen, GELDERLAND, Netherlands, 6525 GA
Status
Recruiting
Location
King's College Hospital NHS Foundation Trust
London, England, United Kingdom, SE5 9RS
Status
Recruiting
Location
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, FORLI-CESENA, Italy, 47014
Status
Recruiting
Location
Hôpital Privé Sévigné
Cesson-Sevigne, BRETAGNE, France, 35576
Status
Recruiting
Location
Fondazione Policlinico Universitario Agostino Gemelli
Roma, Roma, Italy, 00168
Status
Recruiting
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