NCT03185897

Global Epidemiologic Study of Preexisting Immunity to AAV in Adults With Severe Hemophilia

A Global Epidemiologic Study to Determine the Prevalence of Neutralizing Antibodies and Related Adaptive Immune Responses to Adeno-Associated Virus (AAV) in Adults With Hemophilia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 242 (actual)
• Sponsor: Baxalta now part of Shire · Industry
• Sex: Male
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Assess the seroprevalence of neutralizing antibodies (NAb) to AAV in adults with severe hemophilia A (coagulation factor VIII \[FVIII\] \<1%) or moderately severe to severe hemophilia B (coagulation factor IX \[FIX\] ≤2%).

Conditions

• Hemophilia A
• Hemophilia B

Interventions

Type	Name	Description
OTHER	Non-treatment, seroprevalence	Non-treatment study examining the prevalence of preexisting immunity to adeno-associated virus (AAV)

Timeline

• Start date: 2017-06-14
• Primary completion: 2021-03-17
• Completion: 2021-03-17
• First posted: 2017-06-14
• Last updated: 2021-10-25

Locations

23 sites across 6 countries: United States, Austria, France, Germany, Italy, Spain