E07-001: Safety and Efficacy Extension 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:
NCT01194804
First received: August 30, 2010
Last updated: December 5, 2011
Last verified: December 2011

August 30, 2010
December 5, 2011
April 2008
September 2010   (final data collection date for primary outcome measure)
Safety and Efficacy of Eculizumab treatment [ Time Frame: Baseline through Week 26 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01194804 on ClinicalTrials.gov Archive Site
  • Change of LDH [ Time Frame: From baseline ] [ Designated as safety issue: No ]
  • Change of total scores of FACIT-Fatigue scale [ Time Frame: From baseline ] [ Designated as safety issue: No ]
  • Change of PNH RBC [ Time Frame: From baseline ] [ Designated as safety issue: No ]
  • Number of units of Packed RBCs transfused [ Time Frame: From baseline ] [ Designated as safety issue: No ]
  • Lactate dehydrogenase (LDH) area under the curve (AUC) [ Time Frame: From baseline ] [ Designated as safety issue: No ]
  • Change of plasma free Hemoglobin [ Time Frame: From baseline ] [ Designated as safety issue: No ]
  • Change of total EORTC QLQ-C30 score [ Time Frame: From baseline ] [ Designated as safety issue: No ]
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
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; 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
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01194804
E07-001
No
Alexion Pharmaceuticals
Alexion Pharmaceuticals
CMIC Co, Ltd.
Not Provided
Alexion Pharmaceuticals
December 2011

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