Paroxysmal Nocturnal Hemoglobinuria Human Anti-Human Antibodies Study
A Post Marketing, Multi-Center, Trial to Measure Human Anti-Human Antibodies (HAHA) to Soliris (Eculizumab) in Patients With Paroxysmal Nocturnal Hemoglobinuria
1 other identifier
observational
75
10 countries
14
Brief Summary
How does long term treatment with Soliris affect HAHA in PNH patients?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2012
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2011
CompletedFirst Posted
Study publicly available on registry
August 8, 2011
CompletedStudy Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2013
CompletedOctober 18, 2017
October 1, 2017
1.3 years
August 5, 2011
October 16, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To summarize the proportion of patients with neutralizing HAHA antibodies.
Six (6) months
Secondary Outcomes (2)
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
Eligibility Criteria
Patients with PNH previously enrolled in study E05-001, who have a eculizumab naive serum sample available for comparison, and who are currently receiving treatment with commerical Soliris.
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
University Park Hematology Oncology
Englewood, Colorado, 80113, United States
Cleveland Clinic Florida
Weston, Florida, 33331, United States
Maine Cancer Center of Medicine
Scarborough, Maine, 04074, United States
Unknown Facility
Melbourne, Australia
Unknown Facility
Brussels, Belgium
Unknown Facility
Paris, France
Universitatsklinikum Essen
Essen, Germany
Institut fur Klinische Transfusionmedizin und Immungenetick
Ulm, Germany
Unknown Facility
Dublin, Ireland
Azienda Ospediliera Universitatia Careggi
Florence, Italy
Universita degli Studi di Napoli
Napoli, Italy
Unknown Facility
Nijmegen, Netherlands
Unknown Facility
Basel, Switzerland
Unknown Facility
London, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Camille Bedrosian, MD
Alexion Pharmaceuticals, Inc.
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2011
First Posted
August 8, 2011
Study Start
March 1, 2012
Primary Completion
June 1, 2013
Study Completion
June 30, 2013
Last Updated
October 18, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share