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Hemophilia BPhase 3NCT06399289

Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Chinese Subjects With Hemophilia B Previously Treated With FIX Therapy

A Phase 3 study testing Recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP) in people with Hemophilia B, run by CSL Behring at 7 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will investigate the pharmacokinetics (PK), efficacy, and safety of rIX-FP for the routine prophylaxis of bleeding episodes in male Chinese previously treated patients (PTPs) with hemophilia B (FIX activity of ≤ 2%). Read more about this study

Who is it for?
Ages Up to 70 years, men only
Conditions the study is for
Hemophilia B
What is being tested?
Recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
7 sitesChina
Study dates
28 Jul 2024to 7 Jul 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 70 years
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

China7 sites

  • Beijing Children's Hospital

    Beijing, Beijing Municipality, 100045

  • Union Hospital Affiliated to Fujian Medical University

    Fuzhou, Fujian, 350001

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510515

  • Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou, 550004

  • Jinan Central Hospital

    Jinan, Shandong, 250013

  • North China University Of Science And Technology Affiliated Hospital

    Tangshan, Hebei, 63000

  • Hospital of Hematology, Chinese Academy of Medical Sciences

    Tianjin, Tianjin Municipality, 300020

Other trials in China

About this study

Official title: A Phase 3, Open-label, Multicenter, Pharmacokinetics, Efficacy, and Safety Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Previously Treated Chinese Subjects With Hemophilia B

This study will investigate the pharmacokinetics (PK), efficacy, and safety of rIX-FP for the routine prophylaxis of bleeding episodes in male Chinese previously treated patients (PTPs) with hemophilia B (FIX activity of ≤ 2%). In addition to the scheduled rIX-FP prophylaxis regimen, subjects may also receive rIX-FP episodic (on-demand) treatment for breakthrough bleeding episodes and rIX-FP for the prophylaxis and treatment of bleeding in emergency surgical procedures.

Conditions
Hemophilia B
Being tested
Recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP)
Medical subject headings
Hemophilia B

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP)Biological

    Also called rIX-FP, CSL654, Idelvion

    Lyophilized powder for solution for intravenous injection

Study groups in NCT06399289
Study groupRoleWhat they receive
rIX-FPExperimentalSubjects will receive rIX-FP as an intravenous (IV) infusion for a minimum of 50 exposure days (EDs)
Receives: Biological: Recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incremental recovery (IR) (plasma FIX activity)

    Measured: Before, and at 30 minutes after the end of, rIX-FP infusion on Day 1

  2. Maximum plasma concentration (Cmax)

    Measured: Before, and up to 336 hours after the end of, rIX-FP infusion on Day 1

  3. Terminal elimination half-life (t1/2) of rIX-FP

    Measured: Before, and up to 336 hours after the end of, rIX-FP infusion on Day 1

  4. Area under the concentration-time curve (AUC)

    AUC from time zero to the last measurable concentration (plasma FIX activity) (AUC0-last), and AUC from time zero extrapolated to infinity (AUC0-inf).

    Measured: Before, and up to 336 hours after the end of, rIX-FP infusion on Day 1

  5. Clearance (Cl) of rIX-FP

    Measured: Before, and up to 336 hours after the end of, rIX-FP infusion on Day 1

  6. Annualized spontaneous bleeding rate (AsBR)

    AsBR for treated bleeding episodes, by prophylaxis regimen and overall

    Measured: Up to 18 months

  7. Number of subjects who develop an inhibitor to FIX

    Measured: Up to 18 months after rIX-FP infusion

Secondary outcomes (25)

  1. Percentage of area under the concentration-time curve extrapolated (%AUCExt)

    Measured: Before, and up to 336 hours after the end of, rIX-FP infusion on Day 1 and at Week 26 (Repeat PK)

  2. Area under the first moment versus time curve extrapolated to infinity (AUMC0-∞)

    Measured: Before, and up to 336 hours after the end of, rIX-FP infusion on Day 1 and at Week 26 (Repeat PK)

  3. Mean residence time (MRT)

    Measured: Before, and up to 336 hours after the end of, rIX-FP infusion on Day 1 and at Week 26 (Repeat PK)

  4. Apparent volume of distribution during the terminal phase (Vz)

    Measured: Before, and up to 336 hours after the end of, rIX-FP infusion on Day 1 and at Week 26 (Repeat PK)

  5. Apparent volume of distribution at steady-state (Vss)

    Measured: Before, and up to 336 hours after the end of, rIX-FP infusion on Day 1 and at Week 26 (Repeat PK)

  6. Time to reach Cmax (Tmax)

    Measured: Before, and up to 336 hours after the end of, rIX-FP infusion on Day 1 and at Week 26 (Repeat PK)

  7. Elimination rate constant (λz)

    Measured: Before, and up to 336 hours after the end of, rIX-FP infusion on Day 1 and at Week 26 (Repeat PK)

  8. Incremental recovery (IR) (plasma FIX activity) - Repeat PK

    Measured: Before, and at 30 minutes after the end of, rIX-FP infusion at Week 26

  9. Maximum plasma concentration (Cmax) - Repeat PK

    Measured: Before, and up to 336 hours after the end of, rIX-FP infusion at Week 26

  10. Terminal elimination half-life (t1/2) of rIX-FP - Repeat PK

    Measured: Before, and up to 336 hours after the end of, rIX-FP infusion at Week 26

  11. Area under the concentration-time curve (AUC) - Repeat PK

    AUC from time zero to the last measurable concentration (plasma FIX activity) (AUC0-last), and AUC from time zero extrapolated to infinity (AUC0-inf).

    Measured: Before, and up to 336 hours after the end of, rIX-FP infusion at Week 26

  12. Clearance (Cl) of rIX-FP - Repeat PK

    Measured: Before, and up to 336 hours after the end of, rIX-FP infusion at Week 26

  13. Annualized bleeding rate (ABR)

    ABR for treated, untreated, and both treated and untreated bleeding episodes (spontaneous bleeding, traumatic bleeding, unknown bleeding, and total bleeding episodes), by prophylaxis regimen and overall

    Measured: Up to 18 months after rIX-FP infusion

  14. Annualized joint bleeding rate (AjBR)

    AjBR for treated, untreated, and both treated and untreated bleeding episodes, by prophylaxis regimen and overall

    Measured: Up to 18 months after rIX-FP infusion

  15. Clinical evaluation of hemostatic efficacy for major bleeding episodes

    The investigator will rate the efficacy of the rIX-FP treatment for major bleeding episodes based on a hemostatic efficacy four point rating scale of "excellent, good, moderate or no efficacy", by prophylaxis regimen and overall

    Measured: Up to 18 months after rIX-FP infusion

  16. Change in target joints

    Measured: At baseline and up to 18 months after rIX-FP infusion

  17. Consumption of rIX-FP - number of rIX-FP infusions (doses)

    Consumption of rIX-FP expressed as number of rIX-FP infusions (doses), for the prophylaxis regimens, episodic (on-demand) treatment for bleeding episodes (if any), and total (overall) treatment

    Measured: Up to 18 months after rIX-FP infusion

  18. Consumption of rIX-FP - IU/kg per subject per month

    Consumption of rIX-FP expressed as total amount (IU/kg) per subject per month, for the prophylaxis regimens, episodic (on-demand) treatment for bleeding episodes (if any), and total (overall) treatment

    Measured: Up to 18 months after rIX-FP infusion

  19. Consumption of rIX-FP - IU/kg per subject per year

    Consumption of rIX-FP expressed as total amount (IU/kg) per subject per year, for the prophylaxis regimens, episodic (on-demand) treatment for bleeding episodes (if any), and total (overall) treatment.

    Measured: Up to 18 months after rIX-FP infusion

  20. Number of bleeding episodes requiring rIX-FP to achieve hemostasis

    Number of bleeding episodes requiring 1, ≤ 2, or > 2 infusions (doses) of rIX-FP to achieve hemostasis

    Measured: Up to 18 months after rIX-FP infusion

  21. Percentage of bleeding episodes requiring rIX-FP to achieve hemostasis

    Percentage of bleeding episodes requiring 1, ≤ 2, or > 2 infusions (doses) of rIX-FP to achieve hemostasis

    Measured: Up to 18 months after rIX-FP infusion

  22. Number of subjects who develop antibodies against rIX-FP

    Measured: Before, and up to 18 months after, rIX-FP infusion

  23. Number of subjects who develop antibodies against Chinese hamster ovary host cell protein

    Measured: Before, and up to 18 months after, rIX-FP infusion

  24. The number of subjects with treatment emergent adverse events (TEAEs) related to rIX-FP

    Measured: Up to 18 months after rIX-FP infusion

  25. The percentage of subjects with treatment emergent adverse events (TEAEs) related to rIX-FP

    Measured: Up to 18 months after rIX-FP infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2024
  2. Study start28 Jul 2024
  3. Primary completion7 Jul 2026
  4. Study completion7 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06399289
Sponsor's protocol ID
CSL654_3004
Other IDs
2022-002333-34
Status last verified
Jul 2026
First submitted
1 May 2024
Last updated
23 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: CSL will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP) in people with Hemophilia B, run by CSL Behring at 7 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incremental recovery (IR) (plasma FIX activity) (time frame: Before, and at 30 minutes after the end of, rIX-FP infusion on Day 1). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06399289.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.

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