A Post Marketing, Multi-Center, Trial to Measure Human Anti-Human Antibodies (HAHA) to Soliris (Eculizumab) in Patients With Paroxysmal Nocturnal Hemoglobinuria
N/A
N/A
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Open (Enrolling)
Both
Paroxysmal Nocturnal Hemoglobinuria, PNH
Both
Paroxysmal Nocturnal Hemoglobinuria, PNH
Trial Information
A Post Marketing, Multi-Center, Trial to Measure Human Anti-Human Antibodies (HAHA) to Soliris (Eculizumab) in Patients With Paroxysmal Nocturnal Hemoglobinuria
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.
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.
Type of Study:
Observational
Study Design:
Time Perspective: Prospective
Outcome Measure:
To summarize the proportion of patients with neutralizing HAHA antibodies.
Outcome Time Frame:
Six (6) months
Safety Issue:
No
Authority:
United States: Institutional Review Board
Study ID:
M07-003
NCT ID:
NCT01412047
Start Date:
March 2012
Completion Date:
June 2013
Related Keywords:
- Paroxysmal Nocturnal Hemoglobinuria
- PNH
- Paroxysmal Nocturnal Hemoglobinuria
- PNH
- Human Anti-Human Antibody
- HAHA
- Soliris
- eculizumab
- Hemoglobinuria
- Hemoglobinuria, Paroxysmal
Name | Location |
|---|---|
| Cleveland Clinic Florida | Weston, Florida 33331 |
| Maine Cancer Center of Medicine | Scarborough, Maine |
| University Park Hematology Oncology | Englewood, Colorado 80113 |
