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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-010147-14 | EudraCT Number |
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The joint status (knees, ankles) of patients suffering from severe Hemophilia A (too little blood clotting factor VIII in blood) is evaluated in a single magnetic resonance imaging session. No study medication is given.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Experimental |
| |
| Arm 3 | Experimental |
| |
| Arm 4 | Experimental |
| |
| Arm 5 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Drug | Procedure | Patients have received primary FVIII prophylaxis (started < 2 years of age) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum ankle MRI score | no timeframe (single visit, "snapshot" of the actual joint status) |
| Measure | Description | Time Frame |
|---|---|---|
| Total MRI score of the maximum index joint | no timeframe (single visit, "snapshot" of the actual joint status) | |
| Number of bleeds in each index joint over previous 5 years | no timeframe (medical history status) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heidelberg | Baden-Wurttemberg | 69123 | Germany | |||
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| No Drug |
| Procedure |
Patients have received secondary FVIII prophylaxis (started 2 - < 6 years of age) |
|
| No Drug | Procedure | Patients have received secondary FVIII prophylaxis (started 6 - < 12 years of age) |
|
| No Drug | Procedure | Patients have received secondary VIII prophylaxis(started 12 - 18 years of age) |
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| No Drug | Procedure | Patients have received on-demand therapy |
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| Number of total joint bleeds and their locations over previous 5 years | no timeframe (medical history status) |
| Physical joint score (Gilbert Score) | no timeframe (single visit, "snapshot" of the actual joint status) |
| Bonn |
| North Rhine-Westphalia |
| 53105 |
| Germany |
| Münster | North Rhine-Westphalia | 48143 | Germany |
| Magdeburg | Saxony-Anhalt | 39112 | Germany |
| Athens | 115 27 | Greece |
| Milan | 20122 | Italy |
| Padova | 35121 | Italy |
| Parma | 43100 | Italy |
| Roma | 00161 | Italy |
| A Coruña | A Coruña | 15006 | Spain |
| Valencia | Valencia | 46026 | Spain |
| Malmö | 205 02 | Sweden |
| Stockholm | 171 76 | Sweden |
| Canterbury | Kent | CT1 3NG | United Kingdom |
| London | NW3 2QG | United Kingdom |
| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| D006470 | Hemorrhage |
| 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 |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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