Clinical trial NCT05580692: A Prospective Study Evaluating Seroprevalence and Seroconversion of Antibodies Against Adeno-associated Virus (AAV)
Official 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hemophilia A
Lead sponsor: BioMarin Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2022-10-14
Enrollment: 321
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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

Detailed description: This is a multinational, multi-center, 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

Eligibility criteria: Inclusion Criteria:

* Adult Subjects with Hemophilia A

Exclusion Criteria:

* Subject previously treated with AAV vector gene therapy

Primary outcomes:
measure: To qunatify Seroprevalence of antibodies to selected AAV serotypes
timeFrame: 52 weeks
Secondary outcomes:
measure: To describe and characterize selected AAV serotypes antibody responses in adult subjects with Hemophilia A
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Godoy Cruz
country: Argentina
facility: Instituto Hematologia Arbesu
state: Mendoza
city: Corrientes
country: Argentina
facility: Hospital Ramon Jose Vidal
city: Mendoza
country: Argentina
facility: Medico Hematologo
city: Rosario
country: Argentina
facility: Instituto de Hematologia y Medicina Clinica Dr. RUben Davoli
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
city: Murdoch
country: Australia
facility: Haemophilia and Haemostasis Centre Level 1 Cancer Centre South Metropolitan Health Service Fiona Stanley Hospital
city: Wien
country: Austria
facility: Medical University of Vienna
city: Riyadh
country: Saudi Arabia
facility: King Faisal Specialist Hospital & Research Center
city: Riyadh
country: Saudi Arabia
facility: King Saud University Medical City King Saud University
city: Malmö
country: Sweden
facility: Skane University Hospital
city: Solna
country: Sweden
facility: ME Centrum för kliniska cancerstudier - House H3
city: Adana
country: Turkey
facility: Acibadem Adana Hospital
city: Ankara
country: Turkey
facility: Hacettepe University
city: Gaziantep
country: Turkey
facility: Gaziantep University Medical Faculty Sahinbey Educational Research Hospital
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
city: İzmir
country: Turkey
facility: Ege University Medical Faculty
city: Samsun
country: Turkey
facility: Ondokuz Mayis Univ. Med. Fac.
city: Abu Dhabi
country: United Arab Emirates
facility: Sheikh Shakhbout Medical City
Study officials:
affiliation: BioMarin Pharmaceutical
name: Medinfo Medinfo
role: STUDY_DIRECTOR
References: