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NCT04560933 Clinical Trial

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

Hemophilia A Clinical Trial

— SAAVY  

Official title:
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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04560933
Other study ID # 270-701
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date August 25, 2020
Est. completion date December 30, 2023

Study information
Verified date May 2023
Source BioMarin Pharmaceutical
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 1000
Est. completion date December 30, 2023
Est. primary completion date December 30, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Blood sample collection
Blood sample collection

Locations
Country Name City State
United States Covance Inc Madison Wisconsin

Sponsors (1)
Lead Sponsor Collaborator
BioMarin Pharmaceutical

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Assess the Seroprevalence of antibodies to AAV vectors in patients with hemophilia A To assess the Seroprevalence of antibodies to AAV vectors in patients with hemophilia A at Baseline Baseline
Primary Assess the rate of Seroconversion of antibodies to AAV vectors in patients with hemophilia A Change from baseline through Week 12
Secondary To describe and characterize AAV vector titer values in subjects with Hemophilia A To describe and characterize AAV vector titer values in subjects with Hemophilia A Change from baseline through Week 12
Secondary To describe and characterize AAV vector titer values in subjects with Hemophilia A To describe and characterize AAV vector titer values in subjects with Hemophilia A Change from baseline through Week 24
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