Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Chinese Subject… (NCT06399289) | Clinical Trial Compass
CompletedPhase 3
Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Chinese Subjects With Hemophilia B Previously Treated With FIX Therapy
China23 participantsStarted 2024-07-28
Plain-language 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%). 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.
Who can participate
Age range
70 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incremental recovery (IR) (plasma FIX activity)
Timeframe: Before, and at 30 minutes after the end of, rIX-FP infusion on Day 1
2
Maximum plasma concentration (Cmax)
Timeframe: 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
Timeframe: Before, and up to 336 hours after the end of, rIX-FP infusion on Day 1
4
Area under the concentration-time curve (AUC)
Timeframe: Before, and up to 336 hours after the end of, rIX-FP infusion on Day 1
5
Clearance (Cl) of rIX-FP
Timeframe: Before, and up to 336 hours after the end of, rIX-FP infusion on Day 1
6
Annualized spontaneous bleeding rate (AsBR)
Timeframe: Up to 18 months
7
Number of subjects who develop an inhibitor to FIX