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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01562158




Registration number
NCT01562158
Ethics application status
Date submitted
22/03/2012
Date registered
23/03/2012
Date last updated
11/01/2017

Titles & IDs
Public title
Efficacy and Safety of Activated Recombinant Human Factor VII in Treatment of Bleeding in Patients Following Allogeneic Stem Cell Transplantation
Scientific title
A Multi-centre, Randomised, Double-blind, Parallel Groups, Placebocontrolled Trial on Efficacy and Safety of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in Treatment of Bleeding in Patients Following Stem Cell Transplantation (SCT)
Secondary ID [1] 0 0
F7BMT-1360
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acquired Bleeding Disorder 0 0
Bleeding During/Following Surgery 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - standard therapy
Treatment: Drugs - activated recombinant human factor VII
Treatment: Drugs - activated recombinant human factor VII
Treatment: Drugs - activated recombinant human factor VII
Treatment: Drugs - placebo

Placebo Comparator: Placebo -

Experimental: Low dose -

Experimental: Medium dose -

Experimental: High dose -


Treatment: Surgery: standard therapy
Standard treatment of bleeding

Treatment: Drugs: activated recombinant human factor VII
Two days repeated treatment regimen - low dose administered i.v. (into the vein)

Treatment: Drugs: activated recombinant human factor VII
Two days repeated treatment regimen - medium dose administered i.v. (into the vein)

Treatment: Drugs: activated recombinant human factor VII
Two days repeated treatment regimen - high dose administered i.v. (into the vein)

Treatment: Drugs: placebo
Placebo
Intervention code [1] 0 0
Treatment: Surgery
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Effect on bleeding, defined as change in bleeding score
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Transfusion requirements
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Bleeding evaluation
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Adverse events
Timepoint [3] 0 0

Eligibility
Key inclusion criteria
- Patients who have undergone allogeneic or autologous stem cell transplantation
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Known or suspected allergy to trial product

- Participation in other trials with unapproved drugs or trials with equal or similar
objective

Study design
Purpose of the study
Treatment
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?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
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
1/04/2001
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2003
Sample size
Target
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Novo Nordisk Investigational Site - Herston
Recruitment hospital [2] 0 0
Novo Nordisk Investigational Site - Parkville
Recruitment hospital [3] 0 0
Novo Nordisk Investigational Site - Westmead
Recruitment postcode(s) [1] 0 0
4029 - Herston
Recruitment postcode(s) [2] 0 0
3050 - Parkville
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
North Carolina
Country [2] 0 0
Austria
State/province [2] 0 0
Vienna
Country [3] 0 0
Denmark
State/province [3] 0 0
København
Country [4] 0 0
Finland
State/province [4] 0 0
Helsinki
Country [5] 0 0
France
State/province [5] 0 0
Besancon
Country [6] 0 0
France
State/province [6] 0 0
Lille
Country [7] 0 0
France
State/province [7] 0 0
Tours
Country [8] 0 0
Germany
State/province [8] 0 0
Dresden
Country [9] 0 0
Germany
State/province [9] 0 0
Hamburg
Country [10] 0 0
Germany
State/province [10] 0 0
Hannover
Country [11] 0 0
Germany
State/province [11] 0 0
Idar-Oberstein
Country [12] 0 0
Germany
State/province [12] 0 0
Köln
Country [13] 0 0
Germany
State/province [13] 0 0
München
Country [14] 0 0
Germany
State/province [14] 0 0
Regensburg
Country [15] 0 0
Germany
State/province [15] 0 0
Tübingen
Country [16] 0 0
Germany
State/province [16] 0 0
Wiesbaden
Country [17] 0 0
Israel
State/province [17] 0 0
Haifa
Country [18] 0 0
Israel
State/province [18] 0 0
Jerusalem
Country [19] 0 0
Italy
State/province [19] 0 0
Firenze
Country [20] 0 0
Italy
State/province [20] 0 0
Genova
Country [21] 0 0
Italy
State/province [21] 0 0
Pesaro
Country [22] 0 0
Italy
State/province [22] 0 0
Rome
Country [23] 0 0
Italy
State/province [23] 0 0
Udine
Country [24] 0 0
Poland
State/province [24] 0 0
Gdansk
Country [25] 0 0
Poland
State/province [25] 0 0
Katowice
Country [26] 0 0
Poland
State/province [26] 0 0
Poznan
Country [27] 0 0
Poland
State/province [27] 0 0
Warszawa
Country [28] 0 0
Poland
State/province [28] 0 0
Wroclaw
Country [29] 0 0
Singapore
State/province [29] 0 0
Singapore
Country [30] 0 0
Spain
State/province [30] 0 0
Barcelona
Country [31] 0 0
Spain
State/province [31] 0 0
Santander
Country [32] 0 0
Spain
State/province [32] 0 0
Valencia
Country [33] 0 0
Sweden
State/province [33] 0 0
Göteborg
Country [34] 0 0
Sweden
State/province [34] 0 0
Stockholm
Country [35] 0 0
Sweden
State/province [35] 0 0
Uppsala
Country [36] 0 0
Switzerland
State/province [36] 0 0
Basel
Country [37] 0 0
Switzerland
State/province [37] 0 0
Zürich
Country [38] 0 0
Thailand
State/province [38] 0 0
Bangkok
Country [39] 0 0
United Kingdom
State/province [39] 0 0
London
Country [40] 0 0
United Kingdom
State/province [40] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This trial is conducted in Asia, Europe and Oceania. The aim of this trial is to evaluate the
efficacy of placebo and activated recombinant human factor VII in patients having undergone
allogeneic or autologous stem cell transplantation.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01562158
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Global Clinical Registry (GCR, 1452)
Address 0 0
Novo Nordisk A/S
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