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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00122330
Registration number
NCT00122330
Ethics application status
Date submitted
18/07/2005
Date registered
22/07/2005
Date last updated
4/12/2006
Titles & IDs
Public title
Study Using Eculizumab in Transfusion Dependent Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients
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Scientific title
Randomized, Double-Blind, and Placebo-Controlled Study Using Eculizumab in Transfusion Dependent PNH Patients
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Secondary ID [1]
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TRIUMPH
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hemoglobinuria, Paroxysmal
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Condition category
Condition code
Blood
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Haematological diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Eligibility
Key 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
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Educational/counselling/training
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2004
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Date of last participant enrolment
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Actual
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Sample size
Target
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Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
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Recruitment hospital [1]
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Princess Alexandra Hospital, Oncology Haematology Radiation Department - Woolloongabba
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Recruitment hospital [2]
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Queen Elizabeth Hospital, Dept. of Haematology - Woodville South
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Royal Melbourne Hospital, Dept. of Clinical Haematology & Medical Oncology - Parkville
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The Royal Perth Hosptial, Department of Haematology/Level 2 - Perth
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4102 - Woolloongabba
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Recruitment postcode(s) [2]
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5011 - Woodville South
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Recruitment postcode(s) [3]
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3050 - Parkville
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Recruitment postcode(s) [4]
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6000 - Perth
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Recruitment outside Australia
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California
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Alexion Pharmaceuticals, Inc.
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Ethics approval
Ethics application status
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Summary
Brief summary
The primary objective is to evaluate the safety and efficacy of eculizumab in transfusion dependent patients with hemolytic PNH.
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Trial website
https://clinicaltrials.gov/study/NCT00122330
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Trial related presentations / publications
Hillmen P, Young NS, Schubert J, Brodsky RA, Socie G, Muus P, Roth A, Szer J, Elebute MO, Nakamura R, Browne P, Risitano AM, Hill A, Schrezenmeier H, Fu CL, Maciejewski J, Rollins SA, Mojcik CF, Rother RP, Luzzatto L. The complement inhibitor eculizumab in paroxysmal nocturnal hemoglobinuria. N Engl J Med. 2006 Sep 21;355(12):1233-43. doi: 10.1056/NEJMoa061648. Hill A, Rother RP, Wang X, Morris SM Jr, Quinn-Senger K, Kelly R, Richards SJ, Bessler M, Bell L, Hillmen P, Gladwin MT. Effect of eculizumab on haemolysis-associated nitric oxide depletion, dyspnoea, and measures of pulmonary hypertension in patients with paroxysmal nocturnal haemoglobinuria. Br J Haematol. 2010 May;149(3):414-25. doi: 10.1111/j.1365-2141.2010.08096.x. Epub 2010 Mar 8.
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Contacts
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Hillmen P, Young NS, Schubert J, Brodsky RA, Socie...
[
More Details
]
Results not provided in
https://clinicaltrials.gov/study/NCT00122330
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