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NCT05580692 Clinical Trial

A Prospective Study Evaluating Seroprevalence and Seroconversion of Antibodies Against Adeno-associated Virus (AAV)

Hemophilia A Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05580692
Other study ID # 270-702
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 14, 2023
Est. completion date November 2025

Study information
Verified date December 2023
Source BioMarin Pharmaceutical
Contact MedInfo
Phone +1 (800) 983-4587
Email GMI@bmrn.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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

Recruitment information / eligibility
Status Recruiting
Enrollment 400
Est. completion date November 2025
Est. primary completion date October 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult Subjects with Hemophilia A Exclusion Criteria: - Subject previously treated with AAV vector gene therapy

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Biospecimen Collection
Biospecimen Sample Collection

Locations
Country Name City State
Argentina Medico Hematologo Mendoza

Sponsors (1)
Lead Sponsor Collaborator
BioMarin Pharmaceutical

Country where clinical trial is conducted

Argentina, 

Outcome
Type Measure Description Time frame Safety issue
Primary To qunatify Seroprevalence of antibodies to selected AAV serotypes Number of patients with detectable antibodies to selected AAV serotypes 52 weeks
Secondary To describe and characterize selected AAV serotypes antibody responses in adult subjects with Hemophilia A Antibody titer levels measured in target population to selected AAV serotypes 104 weeks
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