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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
Scientific title
Randomized, Double-Blind, and Placebo-Controlled Study Using Eculizumab in Transfusion Dependent PNH Patients
Secondary ID [1] 0 0
TRIUMPH
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hemoglobinuria, Paroxysmal 0 0
Condition category
Condition code
Blood 0 0 0 0
Haematological diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Educational/counselling/training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Princess Alexandra Hospital, Oncology Haematology Radiation Department - Woolloongabba
Recruitment hospital [2] 0 0
Queen Elizabeth Hospital, Dept. of Haematology - Woodville South
Recruitment hospital [3] 0 0
Royal Melbourne Hospital, Dept. of Clinical Haematology & Medical Oncology - Parkville
Recruitment hospital [4] 0 0
The Royal Perth Hosptial, Department of Haematology/Level 2 - Perth
Recruitment postcode(s) [1] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 0 0
5011 - Woodville South
Recruitment postcode(s) [3] 0 0
3050 - Parkville
Recruitment postcode(s) [4] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
Belgium
State/province [12] 0 0
Brussels
Country [13] 0 0
Canada
State/province [13] 0 0
Alberta
Country [14] 0 0
France
State/province [14] 0 0
Paris
Country [15] 0 0
Germany
State/province [15] 0 0
Essen
Country [16] 0 0
Germany
State/province [16] 0 0
Greifswald
Country [17] 0 0
Germany
State/province [17] 0 0
Hannover
Country [18] 0 0
Germany
State/province [18] 0 0
Homburg/Saar
Country [19] 0 0
Germany
State/province [19] 0 0
Ulm
Country [20] 0 0
Ireland
State/province [20] 0 0
Dublin
Country [21] 0 0
Italy
State/province [21] 0 0
Firenze
Country [22] 0 0
Italy
State/province [22] 0 0
Genova
Country [23] 0 0
Italy
State/province [23] 0 0
Milano
Country [24] 0 0
Italy
State/province [24] 0 0
Napoli
Country [25] 0 0
Italy
State/province [25] 0 0
Vicenza
Country [26] 0 0
Netherlands
State/province [26] 0 0
GA
Country [27] 0 0
Sweden
State/province [27] 0 0
Lund
Country [28] 0 0
Sweden
State/province [28] 0 0
Umea
Country [29] 0 0
Switzerland
State/province [29] 0 0
CH
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Cornwall
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Belfast
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Leeds
Country [33] 0 0
United Kingdom
State/province [33] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Alexion Pharmaceuticals, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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

TypeCitations or Other Details
Journal Hillmen P, Young NS, Schubert J, Brodsky RA, Socie... [More Details]

Results not provided in https://clinicaltrials.gov/study/NCT00122330