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The Paroxysmal Nocturnal Hemoglobinuria Early Access Treatment Protocol

Status
APPROVED_FOR_MARKETING
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT00438789
Acronym
EMBRACE
Enrollment
Unknown
Registered
2007-02-22
Start date
Unknown
Completion date
Unknown
Last updated
2014-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemoglobinuria, Paroxysmal

Brief summary

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

Interventions

DRUGeculizumab

600mg IV every week and 900mg IV every 2 weeks

Sponsors

Alexion Pharmaceuticals, Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026