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C07-001: Safety and Efficacy Study of Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients

This study has been completed.
Sponsor:
Collaborator:
CMIC Co, Ltd.
Information provided by (Responsible Party):
Alexion Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01192399
First received: August 30, 2010
Last updated: April 4, 2012
Last verified: April 2012
History of Changes

August 30, 2010
April 4, 2012
November 2007
June 2008   (final data collection date for primary outcome measure)
Change of LDH [ Time Frame: Baseline to Study Week 12 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01192399 on ClinicalTrials.gov Archive Site
  • Change of total scores of FACIT-Fatigue scale [ Time Frame: Baseline to Study Week 12 ] [ Designated as safety issue: No ]
  • Change of PNH RBC count [ Time Frame: Baseline to Study Week 12 ] [ Designated as safety issue: No ]
  • Change of number of units of Packed RBCs transfused [ Time Frame: Baseline through study period ] [ Designated as safety issue: No ]
  • AUC for change of LDH [ Time Frame: From baseline ] [ Designated as safety issue: No ]
  • Change of plasma free hemoglobin [ Time Frame: From baseline to Study Week 12 ] [ Designated as safety issue: No ]
  • Change of EORTC QLQ-C30 score [ Time Frame: From baseline to Study Week 12 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
C07-001: Safety and Efficacy Study of Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients
Phase II Clinical Study of Eculizumab (h5G1.1-mAb) in Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients

Assess the safety and efficacy of Eculizumab in hemolytic PNH patients.

The objective of this study is to assess the safety and efficacy of Eculizumab in hemolytic PNH patients. In addition, pharmacokinetic and pharmacodynamic assessments of Eculizumab will be conducted.
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Paroxysmal Nocturnal Hemoglobinuria
Drug: Eculizumab
Each vial contains 30 mL of 10 mg/mL eculizumab; initial dose of 600 mg weekly for 4 weeks, followed by 900 mg one week later, then maintenance of 900 mg every 2 weeks for duration of 12 weeks.
Other Name: Soliris
Experimental: Eculizumab
Treatment with Eculizumab for patients with PNH
Intervention: Drug: Eculizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
October 2008
June 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Japanese individuals at least 12 years of age
  • Diagnosis of PNH > 6 months
  • One transfusion in the past two years for anemia or anemia-related symptoms
  • LDH level >/= 1.5 x upper limit of normal within 12 weeks

Exclusion Criteria:

  • Platelet count < 30,000/microliters
  • Known or suspected hereditary complement deficiency
  • History of hematopoietic stem cell transplant
  • History of meningococcal disease
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01192399
C07-001
No
Alexion Pharmaceuticals
Alexion Pharmaceuticals
CMIC Co, Ltd.
Study Director: Stephen Squinto, PhD Alexion Pharmaceuticals
Alexion Pharmaceuticals
April 2012

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