The Paroxysmal Nocturnal Hemoglobinuria Early Access Treatment Protocol
EMBRACE
1 other identifier
expanded_access
N/A
1 country
1
Brief Summary
The primary objective is to provide access to eculizumab for PNH patient pending commercial availability.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
1 active site
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
February 20, 2007
CompletedFirst Posted
Study publicly available on registry
February 22, 2007
CompletedMay 6, 2014
September 1, 2011
February 20, 2007
May 5, 2014
Conditions
Interventions
600mg IV every week and 900mg IV every 2 weeks
Eligibility Criteria
You may qualify if:
- PNH;
- At least 18 years old
- Avoid conception; and
- Willing and able to give written informed consent
You may not qualify if:
- Active bacterial infection
- Participation in any other drug trial
- Pregnant breast feeding, or intending to conceive
- Not vaccinated against N meningitidis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Anthony Botti
Livingston, New Jersey, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 20, 2007
First Posted
February 22, 2007
Last Updated
May 6, 2014
Record last verified: 2011-09