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Study of Safety in Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Treated With Eculizumab

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00122304
First Posted: July 22, 2005
Last Update Posted: February 21, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Alexion Pharmaceuticals
July 19, 2005
July 22, 2005
February 21, 2007
December 2004
Not Provided
  • Acceptable safety (adverse events [AEs], labs, electrocardiograms [ECGs], vital signs)
  • Primary surrogate of efficacy endpoint is hemolysis measured by LDH area under the curve.
Acceptable safety (AEs, labs, ECGs, vital signs)
Complete list of historical versions of study NCT00122304 on ClinicalTrials.gov Archive Site
  • Hemolysis measured by the change of LDH from baseline;
  • Quality of Life
  • Hemolysis
  • Quality of Life
Not Provided
Not Provided
 
Study of Safety in Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Treated With Eculizumab
Safety in Hemolytic PNH Patients Treated With Eculizumab: a Multi-Center Open-Label Research Design Study
The primary objective is to evaluate the safety of eculizumab in patients with transfusion-dependent hemolytic PNH
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hemoglobinuria, Paroxysmal
Drug: eculizumab
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
85
November 2006
Not Provided

Inclusion Criteria:

  • PNH > 6 months
  • Type III PNH red blood cell (RBC) clone by flow cytometry >10%
  • At least one transfusion in the past 2 years but no more than 3 transfusions in the past 12 months; or personal beliefs that preclude the use of transfusion with severe hemolytic PNH
  • Lactate dehydrogenase (LDH) >1.5 x upper limit of normal
  • Must avoid conception
  • Willing and able to give written informed consent

Exclusion Criteria:

  • Platelet count of <30,000/mm3
  • Absolute neutrophil count <500/ul
  • Active bacterial infection
  • Hereditary complement deficiency
  • History of bone marrow transplantation
  • Participation in any other investigational drug trial or exposure to other investigational agent, device or procedure within 30 days
  • Pregnant, breast-feeding, or intending to conceive
  • History of meningococcal disease
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   Canada,   France,   Germany,   Ireland,   Italy,   Netherlands,   Spain,   Sweden,   Switzerland,   United Kingdom,   United States
 
 
NCT00122304
SHEPHERD
C04-002
Not Provided
Not Provided
Not Provided
Not Provided
Alexion Pharmaceuticals
Not Provided
Not Provided
Alexion Pharmaceuticals
February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP