The Paroxysmal Nocturnal Hemoglobinuria Early Access Treatment Protocol

Hemoglobinuria, Paroxysmal Clinical Trial

— EMBRACE  

Clinical Trial Details — Status: Approved for marketing

Administrative data

• NCT number: NCT00438789
• Other study ID #: C06-002
• Status: Approved for marketing
• Phase: Phase 3
• First received: February 20, 2007
• Last updated: May 5, 2014

Study information

• Verified date: September 2011
• Source: Alexion Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Expanded Access

Clinical Trial Summary

The primary objective is to provide access to eculizumab for PNH patient pending commercial availability.

Recruitment information / eligibility

• Status: Approved for marketing
• Enrollment: 0
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Hemoglobinuria
• Hemoglobinuria, Paroxysmal

Intervention

Drug:
• eculizumab
600mg IV every week and 900mg IV every 2 weeks

Locations

Country	Name	City	State
United States	Anthony Botti	Livingston	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Alexion Pharmaceuticals

Country where clinical trial is conducted

United States,