Open Label Extension Study of Eculizumab in Patients With Transfusion Dependent PNH
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Paroxysmal Hemoglobinuria, Nocturnal
Both
Paroxysmal Hemoglobinuria, Nocturnal
Trial Information
Open Label Extension Study of Eculizumab in Patients With Transfusion Dependent PNH
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Treatment-emergent adverse events
Outcome Time Frame:
during study up to 30 days post last study drug dosing
Safety Issue:
No
Authority:
United States: Food and Drug Administration
Study ID:
E05-001
NCT ID:
NCT00122317
Start Date:
May 2005
Completion Date:
October 2008
Related Keywords:
- Paroxysmal Hemoglobinuria, Nocturnal
- Transfusion dependent, hemolytic paroxysmal nocturnal hemoglobinuria
- Hemoglobinuria
- Hemoglobinuria, Paroxysmal
Name | Location |
|---|---|
| Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
| Cleveland Clinic Foundation | Cleveland, Ohio 44195 |
| Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
| Stanford University Medical Center, Division of Hematology | Stanford, California 94305-5112 |
| Hartford Hospital, Cancer Clinical Research Office | Hartford, Connecticut 06102 |
| Johns Hopkins University Medical Center | Baltimore, Maryland 21205 |
| National Heart, Lung, and Blood Institute, National Institutes of Health | Bethesda, Maryland 20892 |
| NYU Clinical Cancer Center | New York, New York 10016 |
| Duke University Medical Center, Division Cell Therapy, Heme Malignancies Program | Durham, North Carolina 27710 |
| Cleveland Clinic Florida, Department of Clinical Research | Weston, Florida 33331 |
| Indianapolis University Cancer Center | Indianapolis, Indiana 46202 |
| Mayo Clinic, Divison of Hematology | Rochester, Minnesota 55902 |
| Washington University, Department of Internal Medicine/Division of Hematology | St. Louis, Missouri 63110 |
| Presbyterian Medical Center, PENN Comprehensive Hemophilia & Thombosis Program | Philadelphia, Pennsylvania 19104 |
