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 studied a clotting medication called nonacog beta pegol, which is used in people with haemophilia B (a condition where the blood does not clot properly due to low levels of a protein called Factor IX). The trial was split into two phases: a "pre-prophylaxis" phase, in which 34 participants started and 31 completed, and a "prophylaxis" (regular preventive dosing) phase, in which 51 participants started and 41 completed. A key thing the trial was measuring was whether participants developed "inhibitory antibodies" — meaning the body's immune system producing proteins that could block the medication from working — at different points during the trial. The reported data shows that, for inhibitory antibodies, 2 out of 34 participants in the pre-prophylaxis group had developed them by 50 treatment days and that number remained at 2 by the end of the trial. In the prophylaxis group, 0 participants had developed inhibitory antibodies at 50 treatment days, rising to 2 participants by 100 treatment days and remaining at 2 by the end of the trial. Regarding other medical events recorded during the trial (called adverse events — meaning any unwanted medical occurrence noted while on treatment, not necessarily caused by the medication), the reported data shows that by the end of the trial the pre-prophylaxis group had a total of 134 such events and the prophylaxis group had 794. The number of serious adverse events (those involving hospitalisation, life-threatening situations, or other significant medical concerns) by the end of the trial was 14 in the pre-prophylaxis group and 30 in the prophylaxis group. 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 33134776) ↗
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:
- A parent or guardian must agree to participate and sign a consent form before any trial activities begin
- The patient must be a boy under 6 years old at the time of signing the consent form
- The patient must have been diagnosed with Haemophilia B, with a very low level of clotting Factor IX (2% or below), confirmed by medical records or lab results
- The patient must have had little or no previous treatment with Factor IX products — either never treated before, or treated 3 times or fewer (up to 5 previous exposures to blood products such as transfusions is also acceptable)
Who may not be able to join:
- Patients who have previously developed antibodies (inhibitors) against Factor IX treatments, as shown in medical records
- Patients with a known or suspected allergic reaction to the trial treatment or similar products
- Patients who have already taken part in this specific trial and received a dose of the trial treatment
- Patients who have taken part in another clinical trial and received an experimental medicine within the last 30 days before the screening visit
- Patients who have a blood clotting disorder other than Haemophilia B, whether they were born with it or developed it later
- Patients who have another long-term or serious health condition that the doctor believes could put them at risk or affect their ability to take part safely
- Cases where the patient's parent or legal guardian is unable or unwilling to cooperate, or has a language barrier that prevents them from fully understanding and engaging with the trial
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: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S
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
Number of Participants With Incidence of Inhibitory Antibodies Against Coagulation Factor IX (FIX) (50 Exposure Days); Number of Participants With Incidence of Inhibitory Antibodies Against FIX (100 ED); Number of Participants With Incidence of Inhibitory Antibodies Against FIX (At End of Trial)
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.