Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000764639
Ethics application status
Approved
Date submitted
25/10/2005
Date registered
25/11/2005
Date last updated
25/11/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
The pharmacokinetics of plasma-derived Factor XIII in children
Scientific title
The pharmacokinetics of plasma-derived Factor XIII in children with congential Factor XIII Deficiency.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Congenital Factor XIII deficiency 920 0
Condition category
Condition code
Other 987 987 0 0

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
To assess the pharmacokinetics in children following their "usual" dose of plasma-derived Factor XIII (Fibrogammin P).
Will only be performed once on each subject.
No "intervention" as such.
For each individual participant, sample collection will be over a 28 day time period, following their usual infusion of Factor XIII. This infusion takes approximately 5 minutes.
Intervention code [1] 735 0
Other interventions
Comparator / control treatment
There is no comparison/control group.
Control group

Outcomes
Primary outcome [1] 1310 0
To assess the pharmacokinetics of FXIII in children and compare to literature based on adults.
Timepoint [1] 1310 0
Samples will be collected at eight specified time intervals, spread over 28 days. Timing of samples has been adapted from recommended guidelines from the Scientific and Standardization Committee of the International Society of Thrombosis and Haemostasis. Once all samples are collected for each individual, the data will used to determine the FXIII recovery and FXIII half-life.
Secondary outcome [1] 2348 0
To individualise and optomise treatment regimes in children.
Timepoint [1] 2348 0

Eligibility
Key inclusion criteria
Proven FXIII deficiencypatient registered in the Haemophilia program at the Royal Children's HospitalInformed consent obtainedpatients are receiving or have previously received Fibrogammin P as part of their treatment regime.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with haematocrit <35%patients with platelet count <100active bleeding at the time of testingpatient unable to cooperate with study procedures.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
4
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1084 0
Hospital
Name [1] 1084 0
Royal Children's Hospital
Country [1] 1084 0
Australia
Primary sponsor type
Hospital
Name
Department of Clinical Haematology, Royal Children's Hospital, Parkville, Victoria
Address
Country
Australia
Secondary sponsor category [1] 945 0
None
Name [1] 945 0
Nil
Address [1] 945 0
Country [1] 945 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2388 0
Royal Children's Hospital
Ethics committee address [1] 2388 0
Ethics committee country [1] 2388 0
Australia
Date submitted for ethics approval [1] 2388 0
Approval date [1] 2388 0
Ethics approval number [1] 2388 0

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

Contacts
Principal investigator
Name 35499 0
Address 35499 0
Country 35499 0
Phone 35499 0
Fax 35499 0
Email 35499 0
Contact person for public queries
Name 9924 0
Dr Chris Barnes
Address 9924 0
Department of Clinical Haematology
Royal Children's Hospital
Flemington Road
Parkville VIC 3052
Country 9924 0
Australia
Phone 9924 0
+61 3 93455159
Fax 9924 0
+61 3 93491819
Email 9924 0
[email protected]
Contact person for scientific queries
Name 852 0
Dr Chris Barnes
Address 852 0
Department of Clinical Haematology
Royal Children's Hospital
Flemington Road
Parkville VIC 3052
Country 852 0
Australia
Phone 852 0
+61 3 93455159
Fax 852 0
+61 3 93491819
Email 852 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.