Clinical Trial: Paroxysmal Nocturnal Hemoglobinuria Human Anti-Human Antibodies Study
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: A Post Marketing, Multi-Center, Trial to Measure Human Anti-Human Antibodies (HAHA) to Soliris (Eculizumab) in Patients With Paroxysmal Nocturnal Hemoglobinuria
Brief Summary: How does long term treatment with Soliris affect HAHA in PNH patients?
Detailed Summary: 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.
Sponsor: Alexion Pharmaceuticals
Current Primary Outcome: To summarize the proportion of patients with neutralizing HAHA antibodies. [ Time Frame: Six (6) months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- To summarize the proportion of patients with non-neutralizing HAHA antibodies. [ Time Frame: Six (6) months ]
- To summarize the proportion of patients with increased hemolysis in setting of neutralizing HAHA antibodies. [ Time Frame: Six (6) months ]
Original Secondary Outcome: Same as current
Information By: Alexion Pharmaceuticals
Dates:
Date Received: August 5, 2011
Date Started: March 2012
Date Completion:
Last Updated: April 27, 2017
Last Verified: April 2017
