Status:
COMPLETED
Paroxysmal Nocturnal Hemoglobinuria Human Anti-Human Antibodies Study
Lead Sponsor:
Alexion Pharmaceuticals, Inc.
Conditions:
Paroxysmal Nocturnal Hemoglobinuria
PNH
Eligibility:
All Genders
Brief Summary
How does long term treatment with Soliris affect HAHA in PNH patients?
Detailed Description
To determine the long term effect of Soliris (eculizumab) treatment on the presence of human anti-human antibodies (HAHA) in Paroxysmal Nocturnal Hemoglobinuria (PNH) patients.
Eligibility Criteria
Inclusion
- PNH patients who previously participated in study E05-001;
- Patients who have an eculizumab naive serum sample for comparison;
- Patients who currently used commerical Soliris;
- Patients who are willing and able to gie written informed consent.
Exclusion
- There are no exclusion criteria for this study.
Key Trial Info
Start Date :
March 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2013
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT01412047
Start Date
March 1 2012
End Date
June 30 2013
Last Update
October 18 2017
Active Locations (14)
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1
University Park Hematology Oncology
Englewood, Colorado, United States, 80113
2
Cleveland Clinic Florida
Weston, Florida, United States, 33331
3
Maine Cancer Center of Medicine
Scarborough, Maine, United States, 04074
4
Melbourne, Australia