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

History of Changes

Tracking Information
First Received Date ^ICMJE	August 30, 2010
Last Updated Date	December 5, 2011
Start Date ^ICMJE	April 2008
Primary Completion Date	September 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 2, 2010)	Safety and Efficacy of Eculizumab treatment [ Time Frame: Baseline through Week 26 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01194804 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 2, 2010)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	E07-001: Safety and Efficacy Extension Study of Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients
Official Title ^ICMJE	Phase II Clinical Study of Eculizumab (h5G1.1-mAb) in Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients: Extension Study to C07-001 Protocol
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Paroxysmal Nocturnal Hemoglobinuria
Intervention ^ICMJE	Drug: Eculizumab Each vial contains 30 mL of 10 mg/mL eculizumab; dose of 900 mg intravenous every 14 days. Other Name: Soliris
Study Arm (s)	Experimental: Eculizumab Treatment with eculizumab for patients with PNH who have successfully completed the C07-001 protocol Intervention: Drug: Eculizumab
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	27
Completion Date	March 2011
Primary Completion Date	September 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	12 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01194804
Other Study ID Numbers ^ICMJE	E07-001
Has Data Monitoring Committee	No
Responsible Party	Alexion Pharmaceuticals
Study Sponsor ^ICMJE	Alexion Pharmaceuticals
Collaborators ^ICMJE	CMIC Co, Ltd.
Investigators ^ICMJE	Not Provided
Information Provided By	Alexion Pharmaceuticals
Verification Date	December 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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