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To assess and describe real-life treatment choices for rFâ…§ contained regular prophylaxis/bleeding prevention treatment in pediatric hemophilia patients in China (2007-2013)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Chinese hemophilia A pediatric patients with medical records who had accepted regular prophylaxis, totally/partially with rFâ…§ between Nov. 1st 2007 and May 31st 2013 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY14-2222_Kogenate-FS FVIII | Biological | Depends on Doctor's decision |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of regular prophylaxis | Up to 1.5 years | |
| Prophylaxis infusion dose | Up to 1.5 years | |
| Percentage of rFVIII usage in prophylaxis | Up to 1.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding frequency | Up to 1.5 years | |
| Joint radiographic score | Up to 1.5 years | |
| Joint physical examination score |
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Inclusion Criteria:
Available patient medical data record Written informed consent by parent/legal representative. Consent should be sought from subjects if appropriate
Exclusion Criteria:
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About 300 at most hemophilia boys (2-<18 years) in the representative hemophilia treatment centers (HTCs) with available medical data record, having received rFVIII contained regular prophylaxis between Nov. 1st 2007 and May 31st 2013 will be enrolled from about 15 centers.
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28532239 | Derived | Li C, Zhang X, Zhao Y, Wu R, Hu Q, Xu V, Sun J, Yang R, Li X, Zhou R, Lian S, Gu J, Wu J, Hou Q. Status and trend analysis of prophylactic usage of recombinant factor VIII in Chinese pediatric patients with hemophilia A: ReCare - a retrospective, phase IV, non-interventional study. Curr Med Res Opin. 2017 Sep;33(9):1571-1578. doi: 10.1080/03007995.2017.1333489. Epub 2017 Jun 21. | |
| 28326849 |
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| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Up to 1.5 years |
| Quality of life by questionnaire | Up to 1.5 years |
| Derived |
| Li C, Zhang X, Zhao Y, Wu R, Hu Q, Xu W, Sun J, Yang R, Li X, Zhou R, Lian S, Gu J, Wu J, Hou Q. Long-term efficacy and safety of prophylaxis with recombinant factor VIII in Chinese pediatric patients with hemophilia A: a multi-center, retrospective, non-interventional, phase IV (ReCARE) study. Curr Med Res Opin. 2017 Jul;33(7):1223-1230. doi: 10.1080/03007995.2017.1310720. Epub 2017 Apr 25. |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |