Extension Study of Eculizumab in Patients With Transfusion Dependent Paroxysmal Nocturnal Hemoglobinuria (PNH)
Paroxysmal Hemoglobinuria, Nocturnal
About this trial
This is an interventional treatment trial for Paroxysmal Hemoglobinuria, Nocturnal focused on measuring transfusion dependent, paroxysmal nocturnal hemoglobinuria, hemolytic
Eligibility 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
Sites / Locations
- Stanford University Medical Center, Division of Hematology
- Hartford Hospital, Cancer Clinical Research Office
- Cleveland Clinic Florida, Department of Clinical Research
- Indianapolis University Cancer Center
- Johns Hopkins University Medical Center
- National Heart, Lung, and Blood Institute, National Institutes of Health
- Massachusetts General Hospital
- Mayo Clinic, Divison of Hematology
- Washington University, Department of Internal Medicine/Division of Hematology
- NYU Clinical Cancer Center
- Memorial Sloan Kettering Cancer Center
- Duke University Medical Center, Division Cell Therapy, Heme Malignancies Program
- Cleveland Clinic Foundation
- Presbyterian Medical Center, PENN Comprehensive Hemophilia & Thombosis Program
- Royal North Shore Hospital, Haematology Department
- Princess Alexandra Hospital, Oncology Haematology Radiation Department
- The Queen Elizabeth Hospital, Haematology/Oncology Department
- The Royal Perth Hospital, Department of Haematology/Level 2
- Royal Melbourne Hospital, Department of Clinical Haematology & Medical Oncology
- Ucl St. Luc, Hematology Department
- University of Alberta, Cross Cancer Institute
- London Regional Cancer Centre, Clinical Research Unit Room C3080
- Hopital Saint Louis, Centre d'investigation Clinique
- Universitatsklinikum Essen, Zentrum fur Innere Medizin
- Medizinische Hochschule Hannover, Abt. Hamatologie/Onkologie, Zentrum fur Innere Medizin
- Universitatskliniken des Saarlandes, Innere Medizin 1
- Institut fur Klinische Transfusionmedizin und Immunogenetik, Abtlg. Transfusionmedizin des Univ. Ulm
- St. James's Hospital, Cancer Clinical Trial Office
- Azienda Ospedaliera Universitaria Careggi, Dipartimento di area critica medico-chirurgica
- Ospedale San Martino, Department of Hematology
- Ospedale Maggiore di Milano, Divisione di Ematologia
- Universita degli Studi di Napoli, Divisione di Ematologia, Azienda Universitar Policlinico
- Ospedale San Bortolo, Divisione di Ematologia
- UMC St. Radboud, Department of Hematology
- Hospital Clinic i Provincial, Servicio de Hematologia
- Hospital Universitario Germans Trias I Pujol, Servicio de Hematologia
- Hospital De La Paz, Servicio de Hematologia
- Stockholm South Hospital, Division of Hematology
- Leeds General Infirmary, D Floor Brotherton Wing
- St. George's Hospital, Department of Haematology
Arms of the Study
Arm 1
Experimental
Eculizumab
600 mg intravenous infusion every week x 4 then 900 mg iv every two weeks