Hemophilia A Clinical Trial
— SAAVYOfficial 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
NCT number | NCT04560933 |
Other study ID # | 270-701 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 25, 2020 |
Est. completion date | October 20, 2023 |
Verified date | April 2024 |
Source | BioMarin Pharmaceutical |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
Status | Completed |
Enrollment | 186 |
Est. completion date | October 20, 2023 |
Est. primary completion date | September 20, 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 |
Country | Name | City | State |
---|---|---|---|
United States | Covance Inc | Madison | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
BioMarin Pharmaceutical |
United States,
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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