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

Condition	Intervention	Phase
Transfusion dependent, hemolytic paroxysmal nocturnal hemoglobinuria.	Drug: eculizumab	Phase III

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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:

• Patient who have early terminated from the SHEPHERD or X03-001 studies;
• Patient who have early terminated from the TRIUMPH study due to an adverse event;
• Female whio 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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00122317

California
      Stanford University Medical Center, Division of Hematology, Stanford,  California,  94305,  United States; Not yet recruiting
Connecticut
      Hartford Hospital, Cancer Clinical Research Office, Hartford,  Connecticut,  06102,  United States; Recruiting
Florida
      Cleveland Clinic Florida, Department of Clinical Research, Weston,  Florida,  33331,  United States; Recruiting
Indiana
      Indianapolis University Cancer Center, Indianapolis,  Indiana,  46202,  United States; Recruiting
Maryland
      John Hopkins University Medical Center, Baltimore,  Maryland,  21205,  United States; Recruiting
      National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda,  Maryland,  20892,  United States; Recruiting
Massachusetts
      Massachusetts General Hospital, Boston,  Massachusetts,  02114,  United States; Not yet recruiting
Minnesota
      Mayo Clinic, Divison of Hematology, Rochester,  Minnesota,  55902,  United States; Not yet recruiting
Missouri
      Washington University, Department of Internal Medicine/Division of Hematology, St. Louis,  Missouri,  63110,  United States; Recruiting
New York
      Memorial Sloan Kettering Cancer Center, New York,  New York,  10017,  United States; Not yet recruiting
      NYU Clinical Cancer Center, New York,  New York,  10016,  United States; Recruiting
North Carolina
      Duke University Medical Center, Division Cell Therapy, Heme Malignancies Program, Durham,  North Carolina,  27710,  United States; Recruiting
Ohio
      Cleveland Clinic Foundation, Cleveland,  Ohio,  44195,  United States; Recruiting
Pennsylvania
      Presbyterian Medical Center, PENN Comprehensive Hemophilia & Thombosis Program, Philadelphia,  Pennsylvania,  19104,  United States; Not yet recruiting
Australia
      Royal Melbourne Hospital, Department of Clinical Haematology & Medical Oncology, Parkville,  3050,  Australia; Recruiting
Australia, New South Wales
      Royal North Shore Hospital, Haematology Department, St. Leonard,  New South Wales,  2065,  Australia; Not yet recruiting
Australia, Queensland
      Princess Alexandra Hospital, Oncology Haematology Radiation Department, Woolloongabba,  Queensland,  4102,  Australia; Recruiting
Australia, South Australia
      The Queen Elizabeth Hospital, Haematology/Oncology Department, Woodville South,  South Australia,  5011,  Australia; Recruiting
Australia, Western Australia
      The Royal Perth Hospital, Department of Haematology/Level 2, Perth,  Western Australia,  6000,  Australia; Recruiting
Belgium
      Ucl St. Luc, Hematology Department, Brussels,  1200,  Belgium; Not yet recruiting
Canada, Alberta
      University of Alberta, Cross Cancer Institute, Edmonton,  Alberta,  T6G 2B7,  Canada; Not yet recruiting
Canada, Ontario
      London Regional Cancer Centre, Clinical Research Unit Room C3080, London,  Ontario,  N6A4L6,  Canada; Not yet recruiting
France, Cedex
      Hopital Saint Louis, Centre d''''investigation Clinique, Paris,  Cedex,  10 75475,  France; Not yet recruiting
Germany
      Universitatsklinikum Essen, Zentrum fur Innere Medizin, ESSEN,  D-45147,  Germany; Recruiting
      Medizinische Hochschule Hannover, Abt. Hamatologie/Onkologie, Zentrum fur Innere Medizin, Hannover,  D-30625,  Germany; Recruiting
      Institut fur Klinische Transfusionmedizin und Immunogenetik, Abtlg. Transfusionmedizin des Univ. Ulm, Ulm,  D-89081,  Germany; Recruiting
      Universitatskliniken des Saarlandes, Innere Medizin 1, HOMBURG / SAAR,  D-66421,  Germany; Recruiting
Ireland
      St. James''''s Hospital, Cancer Clinical Trial Office, Dublin,  8,  Ireland; Recruiting
Italy
      Ospedale San Martino, Department of Hematology, Genova,  I-16132,  Italy; Not yet recruiting
      Azienda Ospedaliera Universitaria Careggi, Dipartimento di area critica medico-chirurgica, Firenze,  50139,  Italy; Not yet recruiting
      Ospedale San Bortolo, Divisione di Ematologia, Vicenza,  37-36100,  Italy; Not yet recruiting
      Universita degli Studi di Napoli, Divisione di Ematologia, Azienda Universitar Policlinico, Napoli,  5-80131,  Italy; Not yet recruiting
      Ospedale Maggiore di Milano, Divisione di Ematologia, Milano,  35-20122,  Italy; Not yet recruiting
Netherlands, GA
      UMC St. Radboud, Department of Hematology, Nijmegen,  GA,  6525,  Netherlands; Not yet recruiting
Spain
      Hospital De La Paz, Servicio de Hematologia, Madrid,  28046,  Spain; Not yet recruiting
      Hospital Universitario Germans Trias I Pujol, Servicio de Hematologia, Barcelona,  08916,  Spain; Not yet recruiting
      Hospital Clinic i Provincial, Servicio de Hematologia, Barcelona,  08036,  Spain; Not yet recruiting
Sweden
      Stockholm South Hospital, Division of Hematology, Stockholm,  118-83,  Sweden; Not yet recruiting
United Kingdom
      St. George''''s Hospital, Department of Haematology, London,  SW17OQT,  United Kingdom; Recruiting
      Leeds General Infirmary, D Floor Brotherton Wing, Leeds,  LS1 3EX,  United Kingdom; Recruiting

Study ID Numbers:  E05-001
Record last reviewed:  July 2005
Last Updated:  July 25, 2005
Record first received:  July 21, 2005
ClinicalTrials.gov Identifier:  NCT00122317
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-26