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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low dose emicizumab | Experimental | 2 mg per kilograms per dose in first month, loading every 2 weeks then every 4 weeks |
|
| low dose factor VIII prophylaxis | No Intervention | factor VIII prophylaxis |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "Emicizumab", "HEMLIBRA®" | Drug | low dose |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| spontaneous and traumatic bleeding rate | Using "Annualized bleeding rate" (ABR) | 6 months after start low dose emicizumab as secondary prophylaxis treatment |
| treated spontaneous bleeds, treated joint bleeds | Using "Annualized joint bleeding rate" (AJBR) | 6 months after start low dose emicizumab as secondary prophylaxis treatment |
| The function of the knee, elbow, and ankle joints | Using "Hemophilia Joint Health Score" (HJHS) | 6 months after start low dose emicizumab as secondary prophylaxis treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| NUCHANUN KESSAKORN, MD | Contact | 662-5054639 | nuchanun.ks@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| NUCHANUN KESSAKORN | King Chulalongkorn Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Chulalongkorn Memorial hospital | Recruiting | Bangkok | 10330 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39737816 | Derived | Kessakorn N, Gosriwatana I, Sasipong N, Srichumpuang C, Moonla C, Sosothikul D. Low-Dose Emicizumab Versus Low-/Intermediate-Dose Factor VIII Secondary Prophylaxis for Noninhibitor Haemophilia A Patients With Severe Bleeding Phenotype. Haemophilia. 2025 Jan;31(1):122-131. doi: 10.1111/hae.15146. Epub 2024 Dec 31. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 24, 2023 | Nov 25, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006395 | Hemarthrosis |
| D006467 | Hemophilia A |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C000608208 | emicizumab |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| 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 |