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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
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sample collection | Procedure | Blood sample collection |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Assess the rate of Seroconversion of antibodies to AAV vectors in patients with hemophilia A | Change from baseline through Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| To describe and characterize AAV vector titer values in subjects with Hemophilia A |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects diagnosed with Hemophilia A
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Flach, MD | Covance | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Inc | Madison | Wisconsin | 53704 | United States |
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| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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Blood sample collection for AAVx serotypes
To describe and characterize AAV vector titer values in subjects with Hemophilia A |
| Change from baseline through Week 24 |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |