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Clinical Trials in China / NCT07437404
Recruiting Phase 3

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

NCT07437404 · tracked via the Priya Life Science China tracker
Sponsor
Sinocelltech Ltd
Phase
Phase 3
Started
2024-04-26
Last updated
2026-02-27

Condition(s) studied

Haemophilia A

Investigational drug(s) / intervention(s)

SCT800 prophylaxis and treatment for bleeding events

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.

Study 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.

Eligibility

Sex
MALE
Min age
—
Max age
6 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Incidence of FVIII inhibitor — up to 50-100 Exposure Days
    The percentage of FVIII inhibitor measured by Nijmegen-Bethesda

Trial sites (1)

FacilityCityRegionStatus
Beijing children's hospital Beijing Beijing Municipality Recruiting

More Sinocelltech Ltd. trials in China

Multicenter, Phase I/II Study to Evaluate the Safety, Tolerability, PK and Efficacy of SCT520FF in Patients With nAMD Recruiting
SCTB41 Combined With Chemotherapy in Advanced Squamous Non-Small Cell Lung Cancer Recruiting
SCTB35 and SCTB41 With or Without Chemotherapy in Non-Hodgkin Lymphoma Starting soon
A Study to Evaluate the Efficacy, Safety, and Immunogenicity of SCT1000 in Healthy Women Aged 18-45 Years Active, not recruiting
A First-in-human Study of SCTB35 in Patients With Relapse/Refractory B-cell Non-Hodgkin Lymphoma Starting soon

Other trials for the same condition

A Research Study Looking at Long-term Treatment With Mim8 in People With Haemophilia A Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07437404 on ClinicalTrials.gov ↗ ← All trials in China