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

A Multinational, Multi-center, Prospective Cohort Study Evaluating Seroprevalence and Seroconversion of Antibodies Against Adeno-associated Virus (AAV) Serotypes in Subjects With Hemophilia A

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05580692

Enrollment

321

Registered

2022-10-14

Start date

2023-03-14

Completion date

2024-07-31

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemophilia A

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

Interventions

PROCEDUREBiospecimen Collection

Biospecimen Sample Collection

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adult Subjects with Hemophilia A

Exclusion criteria

* Subject previously treated with AAV vector gene therapy

Design outcomes

Primary

Measure	Time frame	Description
To qunatify Seroprevalence of antibodies to selected AAV serotypes	52 weeks	Number of patients with detectable antibodies to selected AAV serotypes

Secondary

Measure	Time frame	Description
To describe and characterize selected AAV serotypes antibody responses in adult subjects with Hemophilia A	52 weeks	Antibody titer levels measured in target population to selected AAV serotypes

Countries

Argentina, Australia, Austria, Saudi Arabia, Sweden, Turkey (Türkiye), United Arab Emirates

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026