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Study terminated due to business and strategic decision
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| Name | Class |
|---|---|
| Centessa Pharmaceuticals plc | INDUSTRY |
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The primary objective of this study is to obtain prospective baseline documentation of annualized bleeding rates (ABRs) and treatment under standard-of-care (SOC) therapy among participants with hemophilia A or B. Participants in the study may be eligible to enroll in future planned interventional studies to be conducted by Sponsor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Eligible Participants | All Participants diagnosed with severe HemA with or without inhibitors, moderately severe to severe HemB, or HemB with inhibitors will be enrolled and continue to receive their usual hemophilia treatment regimen under SOC therapy. Bleeding episodes and treatment data will be collected during the prospective follow up period in a diary. No intervention will be administered as part of this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention | Other | This is a non-interventional study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Annualized Bleeding Rate (ABR) for Treated Bleeds and All Bleeds | ABR for treated bleeds and all bleeds at the participant and bleed level (excluding bleeding episodes during surgery and/or procedures). | Minimum 12 weeks |
| Average Dose (IU/kg) of Associated Treatment Received for Bleeding Episodes per Hemophilia Product per Time Period and per Bleeding Episode | Minimum 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with severe HemA with or without inhibitors, or moderately severe to severe HemB without inhibitors or HemB with inhibitors treated with SOC on-demand or prophylactic hemophilia therapy.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States | ||
| East Carolina univeristy |
There is no plan to share IPD due to the Sponsor's strategic and data-driven decision to discontinue the global clinical development of SerpinPC.
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| Greenville |
| South Carolina |
| 27834 |
| United States |
| Centre of Haematology named after prof. R. O. Yeolian | Yerevan | Yerevan | 0014 | Armenia |
| Royal Prince Alfred Hospital | Camperdown | Camperdown | NSW 2050 | Australia |
| Fundacao de Desenvolvimento da Unicamp FUNCAMP | Campina | São Paulo | 13083-878 | Brazil |
| HEMOES - Centro de Hemoterapia e Hematologia do ES | Vitória | Vitória | 29047105 | Brazil |
| Hamilton Health Sciences Corporation | Hamilton | Hamilton | L8S 4K1 | Canada |
| Hamilton Health Sciences Corporation | Hamilton | Ontario | L8S4K1 | Canada |
| Unity Health Toronto | Toronto | Toronto | M5B 1W8 | Canada |
| Ain Shams University | Cairo | Cairo Governorate | 1153 | Egypt |
| Hopital Necker - Enfants Malades | Paris | Paris | 75015 | France |
| Hospices Civils de Lyon (HCL) - Hopital Femme-Mere-Enfant (HFME) | Lyon | Rhone | 69500 | France |
| Hôpital Bicêtre | Le Kremlin-Bicêtre | 94270 | France |
| CHU Hotel Dieu | Nantes | 44000 | France |
| University Hospital Frankfurt | Frankfurt am Main | Hesse | 60590 | Germany |
| Universitätsklinikum Carl Gustav Carus Dresden | Dresden | Saxony | 1307 | Germany |
| Klinik fur Angiologie Hamostaseologie Haus 12 A Gerinnungssprechstunde | Berlin | State of Berlin | 10249 | Germany |
| St. Johns Medical College | Bangalore | Bangalore | 560034 | India |
| K J Somaiya Super Speciality Hospital & Research Centre | Mumbai | Mumbai | 400022 | India |
| Christian Medical College & Hospital | Ludhiana | Punjab | 141008 | India |
| Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico | Milan | Milano | 20122 | Italy |
| Azienda Ospedaliero-Universitaria Careggi | Florence | 50134 | Italy |
| Korczowski Bartosz, Gabinet Lekarski | Rzeszów | Podkarpackie Voivodeship | 35-302 | Poland |
| Kl Hemat Now Krwi i Trans USK | Wroclaw | Wrocław | 50-367 | Poland |
| King Edward VIII Hospital | Durban | Durban | 4001 | South Africa |
| Phoenix Pharma (Pty) Ltd | Port Elizabeth | Eastern Cape | 6001 | South Africa |
| Hospital Regional Universitario de Malaga Hospital Carlos Haya - Hospital Materno-Infantil | Málaga | Malaga | 29010 | Spain |
| Hospital Clínico Universitario Virgen de la Arrixaca | Murcia | Murcia | 30120 | Spain |
| Hospital Universitario Miguel Servet | Zaragoza | Zaragoza | 50009 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 8035 | Spain |
| China Medical University Hospital | Taichung | Taichung | 40447 | Taiwan |
| Chung Shan Medical University | Taichung | 40201 | Taiwan |
| Taichung Veterans General Hospital | Taichung | 40705 | Taiwan |
| National Taiwan University Hospital | Taipei | 100226 | Taiwan |
| Ege University Hospital | Izmir | İzmir | 35100 | Turkey (Türkiye) |
| Ege University Medical Faculty Pediatric Hospital | Izmir | 35100 | Turkey (Türkiye) |
| University Hospital of Wales | Cardiff | Cardiff | CF14 4XW | United Kingdom |
| Glasgow Royal Infirmary | Glasgow | Glasgow | G4OSF | United Kingdom |
| Barts and London School of Medicine and Dentistry | London | London | E1 2AT | United Kingdom |
| Royal Free London NHS Foundation Trust | London | London | NW3 2QG | United Kingdom |
| Imperial College Healthcare NHS Trust | London | London | W2 1NY | United Kingdom |
| Southampton General Hospital | Southampton | Southampton | S016 6YD | United Kingdom |
| Royal Victoria Infirmary | Newcastle upon Tyne | Tyne and Wear | NE1 4LP | United Kingdom |
| Kent Canterbury Hospital | Canterbury | CT1 3NG | United Kingdom |
| Central Manchester University Hospitals NHS Foundation Trust - Manchester Royal Infirmary | Manchester | M13 9WL | United Kingdom |
| 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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