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

Completed · Phase 3

Conditions studied: Paroxysmal Hemoglobinuria, Nocturnal

In brief

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

Key facts

Study ID

NCT00122317

Run by

Alexion Pharmaceuticals, Inc.

People needed

187

Starts

2005-05-01

Expected to finish

2008-10-01

Last updated by the study team

2018-03-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Stanford University Medical Center, Division of Hematology — Stanford, California, United States
• Hartford Hospital, Cancer Clinical Research Office — Hartford, Connecticut, United States
• Cleveland Clinic Florida, Department of Clinical Research — Weston, Florida, United States
• Indianapolis University Cancer Center — Indianapolis, Indiana, United States
• Johns Hopkins University Medical Center — Baltimore, Maryland, United States
• National Heart, Lung, and Blood Institute, National Institutes of Health — Bethesda, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Mayo Clinic, Divison of Hematology — Rochester, Minnesota, United States
• Washington University, Department of Internal Medicine/Division of Hematology — St Louis, Missouri, United States
• NYU Clinical Cancer Center — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Duke University Medical Center, Division Cell Therapy, Heme Malignancies Program — Durham, North Carolina, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Presbyterian Medical Center, PENN Comprehensive Hemophilia & Thombosis Program — Philadelphia, Pennsylvania, United States
• Royal North Shore Hospital, Haematology Department — Saint Leonards, New South Wales, Australia
• Princess Alexandra Hospital, Oncology Haematology Radiation Department — Woolloongabba, Queensland, Australia
• The Queen Elizabeth Hospital, Haematology/Oncology Department — Woodville South, South Australia, Australia
• The Royal Perth Hospital, Department of Haematology/Level 2 — Perth, Western Australia, Australia
• Royal Melbourne Hospital, Department of Clinical Haematology & Medical Oncology — Parkville, Australia
• Ucl St. Luc, Hematology Department — Brussels, Belgium
• University of Alberta, Cross Cancer Institute — Edmonton, Alberta, Canada
• London Regional Cancer Centre, Clinical Research Unit Room C3080 — London, Ontario, Canada
• Hopital Saint Louis, Centre d'investigation Clinique — Paris, Cedex, France
• Universitatsklinikum Essen, Zentrum fur Innere Medizin — Essen, Germany
• Medizinische Hochschule Hannover, Abt. Hamatologie/Onkologie, Zentrum fur Innere Medizin — Hanover, Germany

Full record on ClinicalTrials.gov

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