Study Complete
Sponsor ID
20150168

A Study Evaluating the Efficacy and Safety of ABP 959 Compared With Eculizumab in Adult Participants With PNHDAHLIA

Sponsor ID
20150168
Clinicaltrials.gov ID
NCT03818607
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

This is a randomized, double-blind, active-controlled phase 3 study of ABP 959 in participants with paroxysmal nocturnal hemoglobinuria.

Additional Study Details

Phase
Phase 3
Product
ABP 959
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
42
Additional Study Details

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
Status
Contact Us
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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