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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00765726




Registration number
NCT00765726
Ethics application status
Date submitted
2/10/2008
Date registered
3/10/2008
Date last updated
20/01/2012

Titles & IDs
Public title
Study Evaluating The Safety Of Xyntha In Usual Care Settings
Scientific title
A Postauthorization Safety Surveillance Study Of Xyntha In Usual Care Settings
Secondary ID [1] 0 0
B1831003
Secondary ID [2] 0 0
3082B2-4418
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 - Moroctocog alfa(AF-CC)
Treatment: Surgery - Blood draw for laboratory testing

Other: Moroctocog alfa(AF-CC) -


Other interventions: Moroctocog alfa(AF-CC)
Dosing is at the discretion of the investigator during the study

Treatment: Surgery: Blood draw for laboratory testing
Hematology and Chemistry panels, Factor VIII inhibitor and recovery studies

Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Factor VIII (FVIII) Inhibitor Development - FVIII inhibitor development was defined as an inhibitor titer of more than or equal to 0.6 Bethesda Units (BU) using the Nijmegen modification of the Bethesda assay and confirmed by the central laboratory.
Timepoint [1] 0 0
Month 24 or early withdrawal

Eligibility
Key inclusion criteria
- Male patients 12 years of age and older.

- Patients transitioned to Xyntha from other recombinant or plasma-derived FVIII
replacement products.

- Treatment history of 150 or greater exposure days to any FVIII products prior to
Enrollment visit.

- Negative inhibitor at screening or documentation of negative inhibitor titer within 6
weeks or less prior to study entry except for patients entering the study on immune
tolerance induction therapy.
Minimum age
12 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- Bleeding disorder other than hemophilia A.

- Inhibitor titer greater than or equal to 0.6 BU during screening except for patients
on immune tolerance induction therapy.

- Immunomodulatory therapy during screening period.

- Known hypersensitivity to hamster protein.

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
Single group
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
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)
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
District of Columbia
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
Ohio
Country [5] 0 0
New Zealand
State/province [5] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to collect safety information associated with the use of Xyntha
in a usual care setting. Upon meeting eligibility criteria, patients will be required to have
approximately 5 study visits over a 2 year period. Procedures completed throughout the study
include collection of vital signs, physical exams, and laboratory assessments. Patients will
be required to complete an infusion log for each Xyntha infusion.
Trial website
https://clinicaltrials.gov/show/NCT00765726
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
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/show/NCT00765726