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

NCT07437404 | Recruiting Phase 3

• 1 other identifier: SCT800-A304
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Haemophilia A

Keywords

SCT800; haemophilia A; previously untreated patients

Outcome Measures

Primary Outcomes (1)

• Incidence of FVIII inhibitor

  The percentage of FVIII inhibitor measured by Nijmegen-Bethesda

  up to 50-100 Exposure Days

Secondary Outcomes (5)

• The percentage of adverse events

  up to 50-100 exposure days

• annualized bleeding rate

  up to 50-100 exposure days

• annualized joint bleeding rate

  up to 50-100 exposure days

• consumption of SCT800

  up to 50-100 exposure days

• hemostatic effect of SCT800

  up to 50-100 exposure days

Study Arms (1)

SCT800 prophylaxis and control of bleeding events

EXPERIMENTAL

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.

Drug: SCT800 prophylaxis and treatment for bleeding events

Interventions

SCT800 prophylaxis and treatment for bleeding events DRUG

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 control of bleeding events

Eligibility Criteria

• Age: Up to 6 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sinocelltech Ltd.: lead

Study Sites (1)

Beijing children's hospital

Beijing, Beijing Municipality, 000000, China

RECRUITING

MeSH Terms

Conditions

Hemophilia A

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Runhui Wu

CONTACT

+86-13370115037; wurunhuigcp@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Masking Details: Masking Description
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Model Description

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 27, 2026
• Study Start: April 26, 2024
• Primary Completion (Estimated): December 26, 2028
• Study Completion (Estimated): December 26, 2028
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

CN (1)