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New Long-Acting clotting drug could cut bleeding episodes in hemophilia b

NCT ID NCT06399289

Disease control Sponsor: CSL Behring Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 24, 2026 · Updated 3 times

Summary

This phase 3 trial tests a long-acting clotting factor (rIX-FP) in 23 Chinese men with severe hemophilia B. The drug is given regularly to prevent bleeding episodes. Researchers will measure how well it works, how long it lasts in the body, and check for side effects like allergic reactions or inhibitors.

What this could mean

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

Active substance
rIX-FP (a clotting factor IX fused with albumin, brand name Idelvion)
What this could lead to
If successful, this could provide a longer-lasting treatment option for hemophilia B, reducing the frequency of injections needed to prevent bleeding episodes.
What could go wrong
This is a small, open-label trial in Chinese patients only, so results may not apply broadly. There is a risk of allergic reactions or developing inhibitors that block the treatment's effect.

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

23 people

The number who actually took part.

Started

Jul 2024

Finished

Jul 2026

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 70 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 Chinese subjects aged ≤ 70 years * Subjects with documented severe or moderately severe hemophilia B (FIX activity of ≤ 2%) * Subjects have received FIX products for ≥ 150 exposure days (EDs) (subjects aged ≥ 6 years) or ≥ 50 EDs (subjects aged \< 6 years) * Subjects have no confirmed prior history of FIX inhibitor formation Exclusion Criteria: * Known hypersensitivity (allergic reaction or anaphylaxis) to any FIX product or hamster protein. * Known congenital or acquired coagulation disorder other than congenital FIX deficiency. * Currently receiving intravenous (IV) immunomodulating agents such as immunoglobulin or chronic systemic corticosteroid treatment. * Currently receiving a long-acting recombinant FIX treatment such as coagulation factor IX (recombinant), Fc fusion protein (Alprolix®). * Use of traditional or herbal Chinese medicine(s) with an impact on hemophilia, including coagulation, within 28 days before Day 1 and / or refusal to abstain from these during the study until the end of the subject's participation in the study.

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Conditions

The condition(s) this trial relates to.

hemophilia B

As listed by the trial registrant

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

Hemophilia B

Contacts and locations

Locations

  • Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou, 550004, China

  • Beijing Children's Hospital

    Beijing, Beijing Municipality, 100045, China

  • Hospital of Hematology, Chinese Academy of Medical Sciences

    Tianjin, Tianjin Municipality, 300020, China

  • Jinan Central Hospital

    Jinan, Shandong, 250013, China

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510515, China

  • North China University Of Science And Technology Affiliated Hospital

    Tangshan, Hebei, 63000, China

  • Union Hospital Affiliated to Fujian Medical University

    Fuzhou, Fujian, 350001, China

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