Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT01662531) enrolled 27 children with haemophilia B (a condition where the blood lacks enough of a clotting protein called Factor IX). All 27 participants completed the study — none dropped out. The trial was investigating how the body processed a medicine called rIX-FP, a laboratory-made form of Factor IX. Researchers looked at things like how quickly the medicine entered the bloodstream, how long it stayed active in the body, and whether the children's immune systems produced substances (called inhibitors) that could block the medicine from working. The reported data shows that after a single dose of rIX-FP, the medicine remained active in the blood for an average of around 91 hours (roughly 3.8 days), compared to approximately 19 hours for the children's previous Factor IX product. The reported incremental recovery — a measure of how much the clotting protein level in the blood rose per unit of medicine given — was approximately 1.01 for rIX-FP overall, compared to about 0.74 for the previous product. These figures were broadly similar across the two age groups tested (children under 6, and children aged 6 to under 12). The reported data also shows that zero out of 27 participants developed inhibitors to Factor IX during the study. Regarding side effects, the data reports that 26 out of 27 participants experienced at least one adverse event (an unwanted health event recorded during the trial); however, zero participants experienced an adverse event that was considered treatment-related, according to the reported results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 37522479) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Haemophilia Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- The participant must be male and younger than 12 years old.
- They must have severe Hemophilia B, meaning their Factor IX (a blood clotting protein) works at 2% or less of normal levels.
- They must weigh at least 10 kilograms (about 22 pounds).
- They must have already been treated with Factor IX products a certain number of times — more than 150 treatment sessions if aged 6 to under 12, or more than 50 treatment sessions if under 6 years old.
- They must have no personal history of developing antibodies (called "inhibitors") that fight against Factor IX, no detectable inhibitors at the screening appointment, and no family history of such inhibitors.
- A parent or guardian must provide written consent for the child to take part in the study.
Who may not be able to join:
- Anyone with a known allergic reaction to any Factor IX product or to hamster proteins.
- Anyone who has another blood clotting disorder, either one they were born with or one they developed, aside from Hemophilia B.
- Anyone with a known kidney or liver disease.
- Anyone who has recently had a life-threatening bleeding episode.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Program Director, CSL Behring
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
2 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Incremental Recovery Following a Single Intravenous Dose of 50 IU/kg rIX-FP or Previous FIX Product; Half-life (t1/2) Following a Single Intravenous Dose of 50 IU/kg rIX-FP or Previous FIX Product; Area Under the Concentration Versus Time Curve From Time Point Zero to the Last Sample With Quantifiable Drug Concentration (AUClast); Clearance for FIX Activity Following a Single Intravenous Dose of 50 IU/kg rIX-FP or Previous FIX Product; Number of Subjects Developing Inhibitors to Factor IX (FIX)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.