NCT07437404

Efficacy and Safety Evaluation Study of SCT800 in Previously Untreated Hemophilia A Patients.

An Open Label, Uncontrolled Study to Evaluate the the Safety and Efficacy of SCT800 for Prophylaxis Treatment in Severe Previously Untreated Hemophilia Patients.

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Sinocelltech Ltd. · Industry
• Sex: Male
• Age: 6 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Haemophilia A

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-04-26
• Primary completion: 2028-12-26
• Completion: 2028-12-26
• First posted: 2026-02-27
• Last updated: 2026-02-27

Locations

1 site across 1 country: China