Extension Study of Eculizumab in Patients With Transfusion Dependent Paroxysmal Nocturnal Hemoglobinuria (PNH)

Study Identifier:
E05-001
ClinicalTrials.gov Identifier:
NCT00122317
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Study Complete

Study Details

Medical Condition
  • Paroxysmal Hemoglobinuria, Nocturnal
Study Drug
  • Drug: eculizumab
Date
May 2005 - Sep 2008
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • 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 Criteria
  • 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
Sex
Female & Male
Age
18+ years

Study Details

Medical Condition
  • Paroxysmal Hemoglobinuria, Nocturnal
Study Drug
  • Drug: eculizumab
Date
May 2005 - Sep 2008
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • 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 Criteria
  • 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

Protocol Summary

The purpose of this study is to evaluate the long-term safety of eculizumab in patients with transfusion dependent hemolytic PNH.

Trial Locations

Location
Status
Location
Stanford University Medical Center, Division of Hematology
Stanford, California, United States, 94305
Status
N/A
Location
Hartford Hospital, Cancer Clinical Research Office
Hartford, Connecticut, United States, 06102
Status
N/A
Location
Cleveland Clinic Florida, Department of Clinical Research
Weston, Florida, United States, 33331
Status
N/A
Location
Indianapolis University Cancer Center
Indianapolis, Indiana, United States, 46202
Status
N/A
Location
Johns Hopkins University Medical Center
Baltimore, Maryland, United States, 21205
Status
N/A
Location
National Heart, Lung, and Blood Institute, National Institutes of Health
Bethesda, Maryland, United States, 20892
Status
N/A
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