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| Name | Class |
|---|---|
| Sinocelltech Ltd. | INDUSTRY |
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To evaluate the time of response, sustained remission rate, and relapse rate of CD38 monoclonal antibody (Daratumumab) combined with SCT800 (rFVIII) in the treatment of hemophilia A adolescents and adults with high titer inhibitors.
This is a non-randomized controlled trial to compare the outcome of immune tolerance induction therapy usingnon- SCT800 combined with Daratumumab or SCT800 alone in hemophilia A adolescents and adults with high titer inhibitors. Patients will receive Daratumumab combined with SCT800 or SCT800 alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCT800 combined with Daratumumab | Experimental | ITI using low-dose domestic rFVIII (SCT800) (50IU/kg TIW) and treated with Daratumumab 8mg/kg 4-8 times. Other immunosuppressants could be added after 3 months. |
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| SCT800 alone | Active Comparator | ITI using low-dose domestic rFVIII (SCT800) (50IU/kg TIW) alone. Other immunosuppressants could be added after 3 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCT800 and Daratumumab | Drug | SCT800 50IU/kg TIW alone or treated with Daratumumab 8mg/kg 4-8 times |
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| Measure | Description | Time Frame |
|---|---|---|
| success rate of ITI success rate of ITI success rate of ITI success rate of ITI | Inhibitor titre <0.6 BU⁄mL | 12 months |
| Success rate and partial success rate of ITI after 3-month treatment | Inhibitor titre <0.6 BU⁄mL | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| ITI success time | time to successful tolerance | 12 months |
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Inclusion Criteria
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Liu | Contact | +8613820261971 | liuwei1@ihcams.ac.cn | |
| Lei Zhang | Contact | zhanglei1@ihcams.ac.cn |
| Name | Affiliation | Role |
|---|---|---|
| Lei Zhang | Chinese Academy of Medical Science and Blood Disease Hospital | Principal Investigator |
| Renchi Yang | Chinese Academy of Medical Science and Blood Disease Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Recruiting | Tianjin | China |
Data can be requested from the corresponding authors from 12 months to 36 months after study completion
from 12 months to 36 months after study completion
From corresponding author
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| ID | Term |
|---|---|
| C556306 | daratumumab |
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| SCT800 | Drug | SCT800 50IU/kg TIW alone |
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