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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07437404

Enrollment

Registered

2026-02-27

Start date

2024-04-26

Completion date

2028-12-26

Last updated

2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Haemophilia A

Keywords

SCT800, haemophilia A, previously untreated patients

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.

Interventions

DRUGSCT800 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 design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Masking description

Masking Description

Intervention model description

Model Description

Eligibility

Sex/Gender

MALE

Age

No minimum to 6 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Incidence of FVIII inhibitor	up to 50-100 Exposure Days	The percentage of FVIII inhibitor measured by Nijmegen-Bethesda

Secondary

Measure	Time frame	Description
The percentage of adverse events	up to 50-100 exposure days	—
annualized bleeding rate	up to 50-100 exposure days	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)
annualized joint bleeding rate	up to 50-100 exposure days	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).
consumption of SCT800	up to 50-100 exposure days	consumption of SCT800 per month and per year
hemostatic effect of SCT800	up to 50-100 exposure days	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).

Countries

China

Contacts

CONTACTRunhui Wu

wurunhuigcp@163.com+86-13370115037

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026