CClinicalTrials.gg
Approved for marketingNCT00438789EMBRACEUpdated May 6, 2014

The Paroxysmal Nocturnal Hemoglobinuria Early Access Treatment Protocol

An expanded access record providing eculizumab in Hemoglobinuria, Paroxysmal, sponsored by Alexion Pharmaceuticals, Inc.. Approved for marketing at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-05-06.

Sponsored by Alexion Pharmaceuticals, Inc. · Expanded access

Study type
Expanded access
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Hemoglobinuria, Paroxysmal
03

In context

Hemoglobinuria

107 studies on the registry are indexed under Hemoglobinuria; 10 are open to participants now.

Browse Hemoglobinuria studies →

Lead sponsor

Alexion Pharmaceuticals, Inc. is the lead sponsor of 249 studies on the registry; 25 are open to participants now.

Of its 98 completed or terminated interventional studies of FDA-regulated products, 70 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All

Inclusion criteria

  • PNH;
  • At least 18 years old
  • Avoid conception; and
  • Willing and able to give written informed consent

Exclusion criteria

Exclusion Criteria:

  • Active bacterial infection
  • Participation in any other drug trial
  • Pregnant breast feeding, or intending to conceive
  • Not vaccinated against N meningitidis
05

Access details

Study type
Expanded access

Available treatment

  • Drugeculizumab

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

06

Where to request access

1 site
  • Anthony Botti
    Livingston, New Jersey, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00438789
Lead sponsor
Alexion Pharmaceuticals, Inc.
First posted
Feb 22, 2007
Last update
May 6, 2014
View the source record on ClinicalTrials.gov ↗

Requesting access

Expanded access is arranged between your doctor and the company. Ask your care team to contact the provider listed on this record.

No contact was published for this record. The registry link below has the sponsor’s details.

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Discussion

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