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
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
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.
Assess the Seroprevalence of antibodies to AAV vectors in patients with hemophilia A
To describe and characterize AAV vector titer values in subjects with Hemophilia A
Blood sample collection
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
August 25, 2020
April 30, 2023
Primary Completion Date
March 30, 2023
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
18 Years - N/A
Stephen Flach, MD, +447823336138, [email protected]
Stephen Flach, MD, Principal Investigator, Covance