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

BioMarin Pharmaceutical321 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

321

Conditions

Hemophilia A

Interventions

Biospecimen CollectionPROCEDURE

Biospecimen Sample Collection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult Subjects with Hemophilia A Exclusion Criteria: * Subject previously treated with AAV vector gene therapy

Locations (18)

Instituto Hematologia Arbesu

Godoy Cruz, Mendoza Province, Argentina

Hospital Ramon Jose Vidal

Corrientes, Argentina

Outcomes

Primary Outcomes

To qunatify Seroprevalence of antibodies to selected AAV serotypes

Number of patients with detectable antibodies to selected AAV serotypes

Time frame: 52 weeks

Secondary Outcomes

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

Time frame: 52 weeks

Data from ClinicalTrials.gov

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