Status:
COMPLETED
Extension Study of Eculizumab in Patients With Transfusion Dependent Paroxysmal Nocturnal Hemoglobinuria (PNH)
Lead Sponsor:
Alexion Pharmaceuticals, Inc.
Conditions:
Paroxysmal Hemoglobinuria, Nocturnal
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the long-term safety of eculizumab in patients with transfusion dependent hemolytic PNH.
Detailed Description
An open-label extension study to evaluate long-term safety of eculizumab in PNH patients who had completed the TRIUMPH (C04-001), SHEPHERD (C04-002), and X03-001 studies.
Eligibility Criteria
Inclusion
- Patients who have fully completed the TRIUMPH, SHEPHERD, or X03-001 studies
- TRIUMPH patients who have discontinued receiving investigational drug prior to the last visit of the study due to lack of efficacy or exacerbation of symptoms of PNH and have completed all monthly safety and efficacy procedures
- Patient must be willing and able to give written informed consent
- Patient must avoid conception during the trial
Exclusion
- Patients who have terminated early from the SHEPHERD or X03-001 studies
- Patients who have terminated early from the TRIUMPH study due to an adverse event
- Female who is pregnant, breast feeding, or intending to conceive during the course of the study
- Any condition that could increase the patient's risk by participating in the study or could confound the outcome of the study
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
187 Patients enrolled
Trial Details
Trial ID
NCT00122317
Start Date
May 1 2005
End Date
October 1 2008
Last Update
March 13 2018
Active Locations (40)
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1
Stanford University Medical Center, Division of Hematology
Stanford, California, United States, 94305
2
Hartford Hospital, Cancer Clinical Research Office
Hartford, Connecticut, United States, 06102
3
Cleveland Clinic Florida, Department of Clinical Research
Weston, Florida, United States, 33331
4
Indianapolis University Cancer Center
Indianapolis, Indiana, United States, 46202