A Study to Evaluate Seroprevalence and Seroconversion of Antibodies to Adeno-Associated Virus (AAV) in Patients With Hemophilia A

A Prospective, Observational Study Evaluating Seroprevalence and Rate of Seroconversion of Antibodies Against Adeno-associated Virus (AAV) Serotypes and Exploratory Vectors in Subjects With Hemophilia A in the United States

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04560933

Acronym

SAAVY

Enrollment

186

Registered

2020-09-23

Start date

2020-08-25

Completion date

2023-10-20

Last updated

2024-04-24

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

Conditions

Hemophilia A

Brief summary

To quantify the seroprevalence of antibodies to AAV5, AAV6, and AAV8 and the seroconversion rate over varying follow-up intervals in subjects with hemophilia A

Detailed description

This is a single-center, decentralized, patient-centered, prospective, observational study utilizing biospecimen samples collected from hemophilia A subjects across the United States to evaluate and characterize seroprevalence and the rate of seroconversion of antibodies against AAV serotypes and exploratory vectors, and to investigate the associated factors that may influence the vector titers. Relevant medical findings will also be collected from the subject, as well as symptoms related to hemophilia A. The collection of medical history may include major illnesses, diagnoses, and surgeries.

Interventions

PROCEDUREBlood sample collection

Blood sample collection

Study design

Observational model

ECOLOGIC_OR_COMMUNITY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Inclusion criteria

* Subjects diagnosed with Hemophilia A * Subjects aged 18years or over at time of entry

Exclusion criteria

* Currently participating in an interventional study of any investigational product, device or procedure. * Subjects who have been previously treated with AAV vector gene therapy

Design outcomes

Primary

Measure	Time frame	Description
Assess the Seroprevalence of antibodies to AAV vectors in patients with hemophilia A	Baseline	To assess the Seroprevalence of antibodies to AAV vectors in patients with hemophilia A at Baseline
Assess the rate of Seroconversion of antibodies to AAV vectors in patients with hemophilia A	Change from baseline through Week 12	—

Secondary

Measure	Time frame	Description
To describe and characterize AAV vector titer values in subjects with Hemophilia A	Change from baseline through Week 12	To describe and characterize AAV vector titer values in subjects with Hemophilia A

Countries

United States

Outcome results

None listed

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