CompletedNot Applicable

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

United States186 participantsStarted 2020-08-25

Plain-language 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

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Assess the Seroprevalence of antibodies to AAV vectors in patients with hemophilia A

Timeframe: Baseline

Assess the rate of Seroconversion of antibodies to AAV vectors in patients with hemophilia A

Timeframe: Change from baseline through Week 12

Trial details

NCT IDNCT04560933

SponsorBioMarin Pharmaceutical

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-09-20

View on ClinicalTrials.gov More Hemophilia A trials