Efficacy and Safety Evaluation Study of SCT800 in Previously Untreated Hemophilia A Patients.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SCT800 prophylaxis and treatment for bleeding events.
- Who it may be relevant to
- Registry conditions: Haemophilia A. Basic parameters: up to 6 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
An Open Label, Uncontrolled Study to Evaluate the the Safety and Efficacy of SCT800 for Prophylaxis Treatment in Severe Previously Untreated Hemophilia Patients.
Overview
This is an Open Label, Uncontrolled Study to Evaluate the the Safety and Efficacy of SCT800 for Prophylaxis Treatment in Severe Previously Untreated Hemophilia Patients.
Detailed description
SCT800 is a recombinant human coagulation factor VIII, which was on market in 2021 in China. The indication of SCT800 is prophylaxis and control of bleeding events in adult and children, and for the perioperative management of bleeding events. This study continued to evaluate the safety and efficacy of SCT800 in previously untreated patients with severe haemophilia A.
Interventions
- Drug SCT800 prophylaxis and treatment for bleeding events
For prophylaxis, 15-50 IU/kg SCT800 is intravenously. For control of bleeding events(BE), 10-20 IU/kg for mild BE, 15 -30IU/kg for moderate BE, 30-50IU/kg for severe BE.
Primary outcome measures
- Incidence of FVIII inhibitor [Time frame: up to 50-100 Exposure Days]
Secondary outcome measures (5)
- The percentage of adverse events [Time frame: up to 50-100 exposure days]
- annualized bleeding rate [Time frame: up to 50-100 exposure days]
- annualized joint bleeding rate [Time frame: up to 50-100 exposure days]
- consumption of SCT800 [Time frame: up to 50-100 exposure days]
- hemostatic effect of SCT800 [Time frame: up to 50-100 exposure days]
Eligibility criteria
Inclusion criteria
- Male subjects with severe hemophilia A (FVIII:C < 1% in central laboratory tests)
- previously untreated with pdFVIII/rFVIII, including marketed SCT800 (those who have previously used ≤5EDs of blood products such as cryoprecipitate or fresh frozen plasma are acceptable).
- FVIII inhibitor negative
- informed consent.
Exclusion criteria
- Known allergy to recombinant coagulation factor VIII concentrate or any excipient; known allergy to bovine, rodent or hamster bovine;
- subjects with a history or family history of FVIII inhibitor formation;
- Clinical liver function test (ALT、AST) ≥ 5 ULN or clinical kidney function test (BUN，Cr) ≥2 ULN;
- Patients with other coagulation dysfunction diseases in addition to hemophilia A.
- International Normalized Ratio (INR) > 1.5.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
China · 1 center
- Beijing children's hospital — Beijing
Identifiers
NCT: NCT07437404 · SCT800-A304