Study Using Eculizumab in Transfusion Dependent Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients

November 30, 2006 updated by: Alexion Pharmaceuticals

Randomized, Double-Blind, and Placebo-Controlled Study Using Eculizumab in Transfusion Dependent PNH Patients

The primary objective is to evaluate the safety and efficacy of eculizumab in transfusion dependent patients with hemolytic PNH.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

75

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital, Oncology Haematology Radiation Department
    • South Australia
      • Woodville South, South Australia, Australia, 5011
        • Queen Elizabeth Hospital, Dept. of Haematology
    • Victoria
      • Parkville, Victoria, Australia, 3050
        • Royal Melbourne Hospital, Dept. of Clinical Haematology & Medical Oncology
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • The Royal Perth Hosptial, Department of Haematology/Level 2
  • Belgium
      • Brussels, Belgium, 1200
        • Ucl St. Luc, Hematology Department
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • University of Alberta, Cross Cancer Institute
  • France
    • Paris
      • Cedex, Paris, France, 04 75181
        • Hospital De L'Hotel Dieu, Hematologie et Oncologie Medicale
      • Cedex, Paris, France, 10 75475
        • Hopital Saint-Louis, Centre G. Hayem-Secteur Bleu Porte 7, Laboratoire De Pathologie/Greffe de Moelle
  • Germany
      • Essen, Germany, D-45147
        • Universitatsklinikum Essen, Zentrum fur Innere Medizin
      • Greifswald, Germany, D-17487
        • Universitatsklinik Greifswald, Innere Medizin C - Hamato-Onkologie
      • Hannover, Germany, D-30625
        • Medizinische Hochschule Hannover, Abt. Hamatologie/Onkologie, Zentrum fur Innere Medizin
      • Homburg/Saar, Germany, D-66421
        • Saarland University Medical School, Internal Medicine 1
      • Ulm, Germany, D-89081
        • Institut fur Klinische Transfusionmedizin und Immungenetik, Abtlg. Transfusionsmedizin des Universitatskinikums Ulm
  • Ireland
      • Dublin, Ireland, 8
        • St. James Hospital, Haematology Department
  • Italy
      • Firenze, Italy, 50139
        • Azienda Ospedaliera Universitaria Careggi, Dipartimento di area critica medico-chirurgica
      • Genova, Italy, I-16132
        • Ospedale San Martino, Dept. of Hematology
      • Milano, Italy, 35-20122
        • Ospedale Maggiore di Milano, Divisione di Ematologia
      • Napoli, Italy, 5-80131
        • Universitar degli Studi di Napoli, Divisione di Ematologia, Azienda Universitar Policlinico
      • Vicenza, Italy, 37-36100
        • Ospedale San Bortolo, Divisione di Ematologia
  • Netherlands
    • GA
      • Nijmegen, GA, Netherlands, 6525
        • UMC St. Radboud, Dept. of Hematology
  • Sweden
      • Lund, Sweden, SE-22185
        • Lund University Hospital, Department of Internal Medicine, Section of Hematology
      • Umea, Sweden, 90185
        • Umea University Hospital, Dept. of Internal Medicine 3, Section for Hematology
  • Switzerland
    • CH
      • Basel, CH, Switzerland, 4031
        • Universitatsklinik Basel, Division of Hematology
  • United Kingdom
      • Belfast, United Kingdom, BT9 7AB
        • Belfast City Hospital, Dept. of Haematology C Floor
      • Leeds, United Kingdom, LS1 3EX
        • Leeds General Infirmary, D Floor Brotherton Wing
      • London, United Kingdom, SW17 OQT
        • St. George's Hospital, Department of Haematology
    • Cornwall
      • Truro, Cornwall, United Kingdom, TR1 3LJ
        • Royal Cornwall Hospital, Haematology Dept.
  • United States
    • California
      • Duarte, California, United States, 91010-3000
        • City of Hope National Medical Center, Div. of Hematology & Bone Marrow Transplant
      • Los Angeles, California, United States, 90024
        • University of California at Los Angeles
      • San Diego, California, United States, 92121
        • Scripps Cancer Center
      • Stanford, California, United States, 94305-5821
        • Stanford University Medical Center, Division of Hematology
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital, Cancer Clinical Research Office
    • Florida
      • Weston, Florida, United States, 33331
        • Cleveland Clinic, Dept. of Clinical Research
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Cancer Pavilion, Div. of Hematology-Oncology, Hematological Malignancy Program/Immunology
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University Medical Center
      • Bethesda, Maryland, United States, 20892
        • National Heart, Blood, and Lung Institute, National Institutes of Health
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Missouri
      • St. Louis, Missouri, United States, 63110-1093
        • Washington University School of Medicine, Dept. of Internal Medicine/Division of Hematology
    • New York
      • New York, New York, United States, 10016
        • Nyu Clinical Cancer Center
      • New York, New York, United States, 10021
        • Memorial Sloan Kettering Cancer Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Health System, Division of Cell Therapy, Heme Malignancies Program
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Presbyterian Medical Center, PENN Comprehensive Hemophilia & Thrombosis Program

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must have required at least 4 transfusions in the past 12 months
  • PNH type III red blood cell (RBC) clone by flow cytometry of >10%
  • Lactate dehydrogenase (LDH) level > 1.5 x upper limit of normal
  • Platelet count > 100,000/mm3
  • Patient taking erythropoietin must be on a stable dose for at least 26 weeks
  • Patient taking immunosuppressants must be on a stable dose for at least 26 weeks
  • Patient taking corticosteroids must be on a stable dose for at least 4 weeks
  • Patient taking coumadin must be at a stable INR for at least 4 weeks
  • Patient taking iron supplements or folic acid must be on a stable dose for 4 weeks
  • Willing and able to give written informed consent
  • Must avoid conception

Exclusion Criteria:

  • Mean hemoglobin level prior to transfusion over the previous 12 months is >10.5 gm/dl
  • Absolute neutrophil count <500/ul
  • Active bacterial infection
  • Hereditary complement deficiency
  • Participation in any other investigational drug trial or exposure to other investigational agent, device, or procedures within 30 days
  • Pregnant, breast-feeding, or intending to conceive
  • History of meningococcal disease
  • History of bone marrow transplantation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Educational/Counseling/Training
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexion Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Study Completion

January 1, 2006

Study Registration Dates

First Submitted

July 18, 2005

First Submitted That Met QC Criteria

July 19, 2005

First Posted (Estimate)

July 22, 2005

Study Record Updates

Last Update Posted (Estimate)

December 4, 2006

Last Update Submitted That Met QC Criteria

November 30, 2006

Last Verified

November 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRIUMPH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hemoglobinuria, Paroxysmal

Clinical Trials on eculizumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cambodia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe