Paroxysmal Nocturnal Hemoglobinuria Human Anti-Human Antibodies Study
Completed
- Conditions
- PNHParoxysmal Nocturnal Hemoglobinuria
- Registration Number
- NCT01412047
- Lead Sponsor
- Alexion Pharmaceuticals, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
Inclusion Criteria
- 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 Criteria
- There are no exclusion criteria for this study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To summarize the proportion of patients with neutralizing HAHA antibodies. Six (6) months
- Secondary Outcome Measures
Name Time Method To summarize the proportion of patients with non-neutralizing HAHA antibodies. Six (6) months To summarize the proportion of patients with increased hemolysis in setting of neutralizing HAHA antibodies. Six (6) months
Trial Locations
- Locations (7)
Universitatsklinikum Essen
🇩🇪Essen, Germany
Institut fur Klinische Transfusionmedizin und Immungenetick
🇩🇪Ulm, Germany
Azienda Ospediliera Universitatia Careggi
🇮🇹Firenze, Italy
Universita degli Studi di Napoli
🇮🇹Napoli, Italy
Cleveland Clinic Florida
🇺🇸Weston, Florida, United States
University Park Hematology Oncology
🇺🇸Englewood, Colorado, United States
Maine Cancer Center of Medicine
🇺🇸Scarborough, Maine, United States