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Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

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
Secondary ID [2] 0 0
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

Study type
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

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

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
Can healthy volunteers participate?
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
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 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
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
Country [4] 0 0
United States of America
State/province [4] 0 0
Country [5] 0 0
New Zealand
State/province [5] 0 0

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry

Ethics approval
Ethics application status

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
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Pfizer Call Center
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

Summary results
For IPD and results data, please see