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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/NCT00243659




Registration number
NCT00243659
Ethics application status
Date submitted
20/10/2005
Date registered
24/10/2005
Date last updated
3/06/2011

Titles & IDs
Public title
Study Evaluating B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) in Patients With Hemophilia A Undergoing Elective Major Surgery
Scientific title
An Open Label Multi-center Study to Assess the Efficacy and Safety of B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) in Patients With Hemophilia A Undergoing Elective Major Surgery
Secondary ID [1] 0 0
3082B2-311
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hemophilia A 0 0
Condition category
Condition code
Blood 0 0 0 0
Clotting disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - ReFacto AF

Experimental: A -

Experimental: B -


Other interventions: ReFacto AF
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Patients Who Achieved Hemostatic Efficacy After Surgery
Timepoint [1] 0 0
6 weeks
Secondary outcome [1] 0 0
Number of Patients Who Achieved Hemostatic Efficacy at Hospital Discharge
Timepoint [1] 0 0
6 weeks

Eligibility
Key inclusion criteria
- Male, at least 12 years old, with severe hemophilia A undergoing major elective major
surgery requiring FVIII replacement for at least 6 days. Negative FVIII inhibitor test
at screening and no past history of inhibitor.

- Previously treated with at least 150 exposure days to any Factor VIII product

- Normal hepatic and renal function tests and no other bleeding disorder
Minimum age
12 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not 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
1/04/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2008
Sample size
Target
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Perth
Recruitment postcode(s) [1] 0 0
- 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
Michigan
Country [3] 0 0
United States of America
State/province [3] 0 0
North Carolina
Country [4] 0 0
United States of America
State/province [4] 0 0
Pennsylvania
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
United States of America
State/province [6] 0 0
Virginia
Country [7] 0 0
Austria
State/province [7] 0 0
Vienna
Country [8] 0 0
Hungary
State/province [8] 0 0
Budapest
Country [9] 0 0
New Zealand
State/province [9] 0 0
Auckland
Country [10] 0 0
New Zealand
State/province [10] 0 0
Chirstchurch
Country [11] 0 0
Poland
State/province [11] 0 0
Warsawa
Country [12] 0 0
Romania
State/province [12] 0 0
Bucurest
Country [13] 0 0
Sweden
State/province [13] 0 0
Malmö
Country [14] 0 0
Sweden
State/province [14] 0 0
Stockholm

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Wyeth is now a wholly owned subsidiary of Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will examine the efficacy and safety of ReFacto AF in patients with severe and
moderately severe hemophilia A undergoing elective major surgery when administered by either
bolus injections (BI) or continuous infusion (CI).
Trial website
https://clinicaltrials.gov/ct2/show/NCT00243659
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Monitor
Address 0 0
Wyeth is now a wholly owned subsidiary of Pfizer
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00243659