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Sponsor decision to terminate; sufficient sample size for statistical analysis has been achieved.
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A prospective cohort study utilizing biospecimen sample collection from adult Hemophilia A subjects to evaluate and characterize seroprevalence and the seroconversion of antibodies against AAV serotypes
This is a multinational, multi-center, prospective cohort study utilizing biospecimen sample collection from adult Hemophilia A subjects to evaluate and characterize seroprevalence and the seroconversion of antibodies against AAV serotypes
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient Cohort | Experimental | All Patients are within the same arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Biospecimen Sample Collection |
|
| Measure | Description | Time Frame |
|---|---|---|
| To qunatify Seroprevalence of antibodies to selected AAV serotypes | Number of patients with detectable antibodies to selected AAV serotypes | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To describe and characterize selected AAV serotypes antibody responses in adult subjects with Hemophilia A | Antibody titer levels measured in target population to selected AAV serotypes | 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medinfo Medinfo | BioMarin Pharmaceutical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Hematologia Arbesu | Godoy Cruz | Mendoza Province | M5504FKD | Argentina | ||
| Hospital Ramon Jose Vidal |
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| Corrientes |
| W3410 FND |
| Argentina |
| Medico Hematologo | Mendoza | Argentina |
| Instituto de Hematologia y Medicina Clinica Dr. RUben Davoli | Rosario | S2000 CFK | Argentina |
| Royal Prince Alfred Hospital | Camperdown | 2050 | Australia |
| Haemophilia and Haemostasis Centre Level 1 Cancer Centre South Metropolitan Health Service Fiona Stanley Hospital | Murdoch | 6150 | Australia |
| Medical University of Vienna | Vienna | 1090 | Austria |
| King Faisal Specialist Hospital & Research Center | Riyadh | 11211 | Saudi Arabia |
| King Saud University Medical City King Saud University | Riyadh | 12372 | Saudi Arabia |
| Skane University Hospital | Malmö | 205 02 | Sweden |
| ME Centrum för kliniska cancerstudier - House H3 | Solna | SE-171 76 | Sweden |
| Acibadem Adana Hospital | Adana | 01130 | Turkey (Türkiye) |
| Hacettepe University | Ankara | 06100 | Turkey (Türkiye) |
| Gaziantep University Medical Faculty Sahinbey Educational Research Hospital | Gaziantep | 27310 | Turkey (Türkiye) |
| Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty | Istanbul | 34098 | Turkey (Türkiye) |
| Ege University Medical Faculty | Izmir | 35040 | Turkey (Türkiye) |
| Ondokuz Mayis Univ. Med. Fac. | Samsun | 55270 | Turkey (Türkiye) |
| Sheikh Shakhbout Medical City | Abu Dhabi | 11393 | United Arab Emirates |
| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| 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 |
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