NCT07437404RecruitingPhase 3
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.
Source: ClinicalTrials.gov · Last updated 27 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 9 Feb 2026
- Start date
- 26 Apr 2024
- Primary completion date
- 26 Dec 2028
- Lead sponsor
- Sinocelltech Ltd.
- Diseases
- Haemophilia
- NCT number
- NCT07437404
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 36
- From 26 Apr 2024 to the primary completion date, 26 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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;
- Patients with other coagulation dysfunction diseases in addition to hemophilia A.
Lab values
- Clinical liver function test (ALT、AST) ≥ 5 ULN or clinical kidney function test (BUN，Cr) ≥2 ULN;
- International Normalized Ratio (INR) \> 1.5.
Who the study is looking for
- 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.
Age in the registry: - to 6 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Children's Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.