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Clinical Trial NCT07437404 for Haemophilia A is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Efficacy and Safety Evaluation Study of SCT800 in Previously Untreated Hemophilia A Patients. Phase 3 36 Open-Label
Clinical Trial NCT07437404 is designed to study Prevention for Haemophilia A. It is a Phase 3 interventional study that is recruiting, having started on 26 April 2024, with plans to enroll 36 participants. Led by Sinocelltech Ltd., it is expected to complete by 26 December 2028. The latest data from ClinicalTrials.gov was last updated on 27 February 2026.
Brief Summary
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.
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.
Conditions
Haemophilia AOther Study IDs
- SCT800-A304
NCT ID Number
Start Date (Actual)
2024-04-26
Last Update Posted
2026-02-27
Completion Date (Estimated)
2028-12-26
Enrollment (Estimated)
36
Study Type
Interventional
PHASE
Phase 3
Status
Recruiting
Keywords
SCT800
haemophilia A
previously untreated patients
haemophilia A
previously untreated patients
Primary Purpose
Prevention
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalSCT800 prophylaxis and control of 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. | 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
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Incidence of FVIII inhibitor | The percentage of FVIII inhibitor measured by Nijmegen-Bethesda | up to 50-100 Exposure Days |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
The percentage of adverse events | up to 50-100 exposure days | |
annualized bleeding rate | Annualized Bleeding Rate（ABR） can be calculated using the following formula: Number of bleeding events in efficacy evaluation period/(number of days in treatment period/365.25) | up to 50-100 exposure days |
annualized joint bleeding rate | Annualized joint bleeding rate（AJBR） can be calculated using the following formula: Number of joint bleeding events during efficacy evaluation period/(number of days in treatment period/365.25). | up to 50-100 exposure days |
consumption of SCT800 | consumption of SCT800 per month and per year | up to 50-100 exposure days |
hemostatic effect of SCT800 | The investigator shall evaluate the hemostatic effect after the treatment of every bleeding event of subjects based on a four-point scale(excellent, good, moderate, not relieved). | up to 50-100 exposure days |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child
Eligible Sexes
Male
- 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.
- 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.
Sinocelltech Ltd.Study Central Contact
Contact: Runhui Wu, +86-13370115037, [email protected]
1 Study Locations in 1 Countries
Beijing Municipality
Beijing children's hospital, Beijing, Beijing Municipality, 000000, China
Runhui Wu, Contact, 86-13512078851, [email protected]
Recruiting