Back to resultsThe Paroxysmal Nocturnal Hemoglobinuria Early Access Treatment Protocol (EMBRACE)
Primary Purpose
Hemoglobinuria, Paroxysmal
Status
Approved for marketing
Phase
Locations
United States
Study Type
Expanded Access
Intervention
eculizumab
Sponsored by
About this trial
This is an expanded access trial for Hemoglobinuria, Paroxysmal
Eligibility Criteria
Inclusion Criteria:
- PNH;
- At least 18 years old
- Avoid conception; and
- Willing and able to give written informed consent
Exclusion Criteria:
- Active bacterial infection
- Participation in any other drug trial
- Pregnant breast feeding, or intending to conceive
- Not vaccinated against N meningitidis
Sites / Locations
- Anthony Botti
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00438789
Brief Title
The Paroxysmal Nocturnal Hemoglobinuria Early Access Treatment Protocol
Acronym
EMBRACE
Study Type
Expanded Access
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Approved for marketing
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Alexion
4. Oversight
5. Study Description
Brief Summary
The primary objective is to provide access to eculizumab for PNH patient pending commercial availability.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemoglobinuria, Paroxysmal
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
eculizumab
Intervention Description
600mg IV every week and 900mg IV every 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria:
PNH;
At least 18 years old
Avoid conception; and
Willing and able to give written informed consent
Exclusion Criteria:
Active bacterial infection
Participation in any other drug trial
Pregnant breast feeding, or intending to conceive
Not vaccinated against N meningitidis
Facility Information:
Facility Name
Anthony Botti
City
Livingston
State/Province
New Jersey
Country
United States
12. IPD Sharing Statement
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The Paroxysmal Nocturnal Hemoglobinuria Early Access Treatment Protocol
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