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New hope for kids with hemophilia: can SCT800 stop bleeds before they start?

NCT ID NCT07437404

Disease control Sponsor: Sinocelltech Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study is testing a drug called SCT800, a lab-made clotting factor, to prevent bleeding episodes in 36 boys with severe hemophilia A who have never been treated before. Participants receive regular infusions of SCT800, and researchers will monitor how many bleeding events occur and whether the body develops antibodies that could block the treatment. The goal is to see if this approach is safe and effective for long-term prevention.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SCT800 (a recombinant factor VIII replacement therapy)
What this could lead to
If successful, this could provide a safe and effective preventive treatment option for children with severe hemophilia A who have not yet received any factor VIII therapy.
What could go wrong
This is a small, open-label study with no control group, so results may be less reliable. There is a risk of developing inhibitors (antibodies) that block the treatment's effect, a known complication in previously untreated patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 36 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2024

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 6 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

hemophilia A severe hemophilia A

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Haemophilia A

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beijing children's hospital

    RECRUITING

    Beijing, Beijing Municipality, 000000, China

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