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Open Label Extension Study of Eculizumab in Patients With Transfusion Dependent PNH


Phase 3
18 Years
N/A
Not Enrolling
Both
Paroxysmal Hemoglobinuria, Nocturnal

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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 CenterNew York, New York  10021
Cleveland Clinic FoundationCleveland, Ohio  44195
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Stanford University Medical Center, Division of HematologyStanford, California  94305-5112
Hartford Hospital, Cancer Clinical Research OfficeHartford, Connecticut  06102
Johns Hopkins University Medical CenterBaltimore, Maryland  21205
National Heart, Lung, and Blood Institute, National Institutes of HealthBethesda, Maryland  20892
NYU Clinical Cancer CenterNew York, New York  10016
Duke University Medical Center, Division Cell Therapy, Heme Malignancies ProgramDurham, North Carolina  27710
Cleveland Clinic Florida, Department of Clinical ResearchWeston, Florida  33331
Indianapolis University Cancer CenterIndianapolis, Indiana  46202
Mayo Clinic, Divison of HematologyRochester, Minnesota  55902
Washington University, Department of Internal Medicine/Division of HematologySt. Louis, Missouri  63110
Presbyterian Medical Center, PENN Comprehensive Hemophilia & Thombosis ProgramPhiladelphia, Pennsylvania  19104