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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05580692
Registration number
NCT05580692
Ethics application status
Date submitted
16/09/2022
Date registered
14/10/2022
Date last updated
19/08/2024
Titles & IDs
Public title
A Prospective Study Evaluating Seroprevalence and Seroconversion of Antibodies Against Adeno-associated Virus (AAV)
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Scientific title
A Multinational, Multi-center, Prospective Cohort Study Evaluating Seroprevalence and Seroconversion of Antibodies Against Adeno-associated Virus (AAV) Serotypes in Subjects With Hemophilia A
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Secondary ID [1]
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270-702
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hemophilia A
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Condition category
Condition code
Blood
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Clotting disorders
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Human Genetics and Inherited Disorders
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0
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Surgery - Biospecimen Collection
Experimental: Patient Cohort - All Patients are within the same arm
Treatment: Surgery: Biospecimen Collection
Biospecimen Sample Collection
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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To qunatify Seroprevalence of antibodies to selected AAV serotypes
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Assessment method [1]
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Number of patients with detectable antibodies to selected AAV serotypes
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Timepoint [1]
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52 weeks
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Secondary outcome [1]
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To describe and characterize selected AAV serotypes antibody responses in adult subjects with Hemophilia A
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Assessment method [1]
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Antibody titer levels measured in target population to selected AAV serotypes
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Timepoint [1]
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52 weeks
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Eligibility
Key inclusion criteria
* Adult Subjects with Hemophilia A
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Subject previously treated with AAV vector gene therapy
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Study design
Purpose of the study
Other
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Allocation to intervention
Not applicable
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
14/03/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/07/2024
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Sample size
Target
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Accrual to date
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Final
321
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [2]
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Haemophilia and Haemostasis Centre Level 1 Cancer Centre South Metropolitan Health Service Fiona Stanley Hospital - Murdoch
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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6150 - Murdoch
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Recruitment outside Australia
Country [1]
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Argentina
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State/province [1]
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Mendoza
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Argentina
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State/province [2]
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Corrientes
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Argentina
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State/province [3]
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Rosario
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Country [4]
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Austria
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State/province [4]
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Wien
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Country [5]
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Saudi Arabia
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State/province [5]
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Riyadh
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Country [6]
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Sweden
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State/province [6]
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Malmö
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Country [7]
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Sweden
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State/province [7]
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Solna
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Country [8]
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Turkey
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State/province [8]
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Adana
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Country [9]
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Turkey
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State/province [9]
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Ankara
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Country [10]
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Turkey
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State/province [10]
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Gaziantep
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Country [11]
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Turkey
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State/province [11]
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Istanbul
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Country [12]
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Turkey
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State/province [12]
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Izmir
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Country [13]
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Turkey
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State/province [13]
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Samsun
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Country [14]
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United Arab Emirates
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State/province [14]
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Abu Dhabi
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
BioMarin Pharmaceutical
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
A prospective cohort study utilizing biospecimen sample collection from adult Hemophilia A subjects to evaluate and characterize seroprevalence and the seroconversion of antibodies against AAV serotypes
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Trial website
https://clinicaltrials.gov/study/NCT05580692
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Medinfo Medinfo
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Address
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BioMarin Pharmaceutical
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05580692
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