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E07-001: Safety and Efficacy Extension Study of Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01194804
First Posted: September 3, 2010
Last Update Posted: February 17, 2017
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.
Collaborator:
CMIC Co, Ltd. Japan
Information provided by (Responsible Party):
Alexion Pharmaceuticals
August 30, 2010
September 3, 2010
February 17, 2017
April 2008
September 2010   (Final data collection date for primary outcome measure)
Safety and Efficacy of Eculizumab treatment [ Time Frame: Baseline through Week 26 ]
Same as current
Complete list of historical versions of study NCT01194804 on ClinicalTrials.gov Archive Site
  • Change of LDH [ Time Frame: From baseline ]
  • Change of total scores of FACIT-Fatigue scale [ Time Frame: From baseline ]
  • Change of PNH RBC [ Time Frame: From baseline ]
  • Number of units of Packed RBCs transfused [ Time Frame: From baseline ]
  • Lactate dehydrogenase (LDH) area under the curve (AUC) [ Time Frame: From baseline ]
  • Change of plasma free Hemoglobin [ Time Frame: From baseline ]
  • Change of total EORTC QLQ-C30 score [ Time Frame: From baseline ]
Same as current
Not Provided
Not Provided
 
E07-001: Safety and Efficacy Extension Study of Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients
Phase II Clinical Study of Eculizumab (h5G1.1-mAb) in Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients: Extension Study to C07-001 Protocol
The objective of this study is to assess the long term safety of Eculizumab in hemolytic PNH patients who completed the 4 weeks screening and 12 weeks treatment period of C07-001 study. In addition, pharmacokinetic and pharmacodynamic assessments of Eculizumab will be conducted.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Paroxysmal Nocturnal Hemoglobinuria
Drug: Eculizumab
Each vial contains 30 mL of 10 mg/mL eculizumab; dose of 900 mg intravenous every 14 days.
Other Name: Soliris
Experimental: Eculizumab
Treatment with eculizumab for patients with PNH who have successfully completed the C07-001 protocol
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
27
March 2011
September 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients must have fully completed C07-001 study 12-week treatment period

Exclusion Criteria:

  • Patients who terminated early from the C07-001 study
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01194804
E07-001
No
Not Provided
Not Provided
Alexion Pharmaceuticals
Alexion Pharmaceuticals
CMIC Co, Ltd. Japan
Not Provided
Alexion Pharmaceuticals
February 2017

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