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Participants will be assigned to A or B groups with a scale of 1:1 based on a prospectively randomized treatment-sequence assignment, i.e. infuse SCT800 followed by Xyntha (group A), or the alternate sequence (group B). All participants who completed the SCT800HA1 study will enter the efficacy and safety study (Protocol No.: SCT800HA3).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | a single dose administration of SCT800 followed by Xyntha (50 IU.kg-1, based upon the manufacturer's labeled potency) |
|
| Group B | Experimental | a single dose administration of Xyntha followed by SCT800(50 IU.kg-1, based upon the manufacturer's labeled potency) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCT800 | Biological |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incremental Recovery (K-value) | One-stage aPTT Assay | 1hour after the end of the infusion |
| Area Under the Plasma Concentration Versus Time Curve From 0 to 48 Hours (AUClast) | One-stage aPTT Assay | 48 hours after the end of the infusion |
| Elimination Phase Half-life (t1/2) | One-stage aPTT Assay | 48 hours after the end of the infusion |
| Factor VIII (FVIII) Clearance (CL) | One-stage aPTT Assay | 48 hours after the end of the infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration Versus Time Curve From 0 to Infinity (AUC∞) | One-stage aPTT Assay | 48 hours after the end of the infusion |
| FVIII Maximum Plasma Concentration (Cmax) | One-stage aPTT Assay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xie lan Zhao, PhD | Xiangya Hospital of Centre-South University, Changsha, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya Hospital of Centre-South University | Changsha | Hunan | 410008 | China |
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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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| ID | Term |
|---|---|
| C078147 | F8 protein, human |
| D005169 | Factor VIII |
| ID | Term |
|---|---|
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Xyntha |
| Biological |
|
|
| 3 hours after the end of the infusion |
| Mean Residence Time (MRT) | One-stage aPTT Assay | 48 hours after the end of the infusion |
| Volume of Distribution at Steady State (Vss) | One-stage aPTT Assay | 48 hours after the end of the infusion |
| Incidence of inhibitors | 72 hours after the end of the infusion |
| AEs related to SCT800 during treatment and observation of the clinical study | 48 hours after the end of the infusion |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D011498 |
| Protein Precursors |
| D001685 | Biological Factors |