Eculizumab Pharmacokinetics/Pharmacodynamics Study in Pediatric/Adolescent Paroxysmal Nocturnal Hemoglobinuria (PNH)

Study Identifier:
M07-005
ClinicalTrials.gov Identifier:
NCT00867932
EudraCT Identifier:
2009-010402-11
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Study Complete

Study Details

Medical Condition
  • Unmapped
Study Drug
  • Drug: Eculizumab
Date
Oct 2009 - May 2011
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 2 - 17 Years
Requirements Information
Sex
Female & Male
Age
2 - 17 Years

Study Details

Medical Condition
  • Unmapped
Study Drug
  • Drug: Eculizumab
Date
Oct 2009 - May 2011
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 2 - 17 Years years
Requirements Information

Protocol Summary

The primary objective of this study was to evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) parameter estimates of eculizumab to confirm the dose regimens for pediatric and adolescent participants with PNH.

Trial Locations

Location
Status
Location
Orange, California, United States, 92868
Status
N/A
Location
Pensacola, Florida, United States, 32504
Status
N/A
Location
Memphis, Tennessee, United States, 38105
Status
N/A