The Paroxysmal Nocturnal Hemoglobinuria Early Access Treatment Protocol

Study Identifier:
C06-002
ClinicalTrials.gov Identifier:
NCT00438789
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Other

Study Details

Medical Condition
  • Hemoglobinuria, Paroxysmal
Study Drug
  • Drug: eculizumab
Date
N/A - N/A
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion 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
Sex
Female & Male
Age
18+ years

Study Details

Medical Condition
  • Hemoglobinuria, Paroxysmal
Study Drug
  • Drug: eculizumab
Date
N/A - N/A
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion 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

Protocol Summary

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

Trial Locations

Location
Status
Location
Anthony Botti
Livingston, New Jersey, United States
Status
N/A