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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%).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemophilia A | Participants with hemophilia A |
| |
| Hemophilia B | Participants with hemophilia B |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-treatment, seroprevalence | Other | Non-treatment study examining the prevalence of preexisting immunity to adeno-associated virus (AAV) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of neutralizing antibodies (NAb) - Baseline visit | Prevalence of NAb to naturally occurring adeno-associated virus (AAV) serotypes | Baseline visit |
| Prevalence of neutralizing antibodies (NAb) - Year 1 Visit | Prevalence of NAb to naturally occurring adeno-associated virus (AAV) serotypes | Year 1 visit |
| Prevalence of neutralizing antibodies (NAb) - Year 2 Visit | Prevalence of NAb to naturally occurring adeno-associated virus (AAV) serotypes | Year 2 visit |
| Prevalence of neutralizing antibodies (NAb) - Year 3 Visit | Prevalence of NAb to naturally occurring adeno-associated virus (AAV) serotypes | Year 3 visit |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of NAb to AAV including AAV2 and AAV8 | Prevalence of neutralizing antibodies (NAb) to adeno-associated virus (AAV) including AAV2 and AAV8 | Baseline visit, Year 1 visit, Year 2 visit, and Year 3 visit |
| Prevalence of binding antibodies to AAV, including AAV8 and AAV2 |
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Inclusion Criteria:
Exclusion Criteria:
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Hemophilia A and hemophilia B patients who receive treatment at Hemophilia Treatment Centers.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Shire | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopaedic Hemophilia Treatment Center | Los Angeles | California | 90007 | United States | ||
| University of Colorado Hemophilia & Thrombosis Center |
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| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link | View source |
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Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
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Prevalence of binding antibodies to adeno-associated virus (AAV), including AAV8 and AAV2 |
| Baseline visit, Year 1 visit, Year 2 visit, and Year 3 visit |
| T-cell mediated immune response to AAV8 | T-cell mediated immune response to AAV8 | Baseline visit, Year 1 visit, Year 2 visit, and Year 3 visit |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Michigan State University | East Lansing | Michigan | 48824 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Medical University of South Carolina (MUSC) | Charleston | South Carolina | 29425 | United States |
| Gulf States Hemophilia and Thrombophilia Center | Houston | Texas | 77030 | United States |
| University of Washington | Seattle | Washington | 98104 | United States |
| AKH - Medizinische Universität Wien | Vienna | 1090 | Austria |
| Hôpital Morvan | Brest | 29609 | France |
| Groupement Hospitalier Est- Hôpital Louis Pradel | Bron | 69677 | France |
| Groupement Hospitalier Sud - Hôpital Bicêtre | Le Kremlin-Bicêtre | 94275 | France |
| Hopital Jeanne de Flandre - CHU Lille | Lille | 59037 | France |
| Hôpital de la Timone | Marseille | 13385 | France |
| CHU de Nantes Site Hotel Dieu | Nantes | 44093 | France |
| Vivantes Klinikum im Friedrichshain | Berlin | 10249 | Germany |
| Klinikum der Johann Wolfgang Goethe-Universitaet | Frankfurt | 60590 | Germany |
| Presidio Ospedaliero di Castelfranco Veneto | Castelfranco Veneto | 31033 | Italy |
| Azienda Ospedaliera Universitaria Careggi | Florence | 50134 | Italy |
| Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico | Milan | 20122 | Italy |
| Ospedale San Bortolo di Vicenza | Vicenza | 36100 | Italy |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital Regional Universitario de Malaga | Málaga | 29010 | Spain |
| Hospital Universitario de Salamanca | Salamanca | 37007 | Spain |
| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| D002836 | Hemophilia B |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D040181 | Genetic Diseases, X-Linked |
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| ID | Term |
|---|---|
| D016036 | Seroepidemiologic Studies |
| ID | Term |
|---|---|
| D016021 | Epidemiologic Studies |
| D016020 | Epidemiologic Study Characteristics |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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