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

BioMarin Pharmaceutical

Status: Terminated

Conditions: Hemophilia A

Treatments: Procedure: Biospecimen Collection

Study type: Interventional

Funder types: Industry

Identifiers

NCT05580692

270-702

Details and patient eligibility

About

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

Full 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

Enrollment: 321 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult Subjects with Hemophilia A

Exclusion criteria

• Subject previously treated with AAV vector gene therapy

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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321 participants in 1 patient group

Patient Cohort

Experimental group

Description:

All Patients are within the same arm

Treatment:

Procedure: Biospecimen Collection