Phase 3 Haemophilia Trial, Recruiting
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:
- You must be able to give your agreement to take part, or if you are under 18 or unable to give consent yourself, a parent or legal representative must be able to do this on your behalf.
- You must have already completed one of four specific previous studies (Sobi.BIVV001-001, Sobi.BIVV001-003, LTS16294, or Sobi.BIVV001-004) and the study doctor must believe you are benefiting from the treatment called efanesoctocog alfa.
- You (or your parent or legal representative) must be willing and able to learn how to use a study diary app or form and fill it in throughout the trial.
Who may not be able to join:
- You may not be able to join if a blood test at your first study visit shows that your body has developed a resistance to the treatment (called an inhibitor), at a level of 0.6 Bethesda units per millilitre or higher.
- You may not be able to join if you are currently taking part in, or planning to take part in, another clinical study at the time of your first visit.
- You may not be able to join if the study doctor decides for any reason — including your medical or health conditions, or concerns about your ability to follow the study procedures — that this trial is not right for you.
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: Medical Development Lead, Sobi AB
Phone: +46 (0)8 697 20 00
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
Primary endpoints
Number of injections to treat a bleeding episode; Total dose to treat a bleeding episode; Adverse events (AEs), including serious adverse events (SAEs) and adverse events of special interest (AESIs); Annualized bleeding rate (ABR) for treated bleeding episodes; Annualized bleeding rate (ABR) for treated bleeding episodes by type of bleed; Annualized bleeding rate (ABR) for treated bleeding episodes by location of bleed; Annualized bleeding rate (ABR) for all bleeding episodes; Annualized bleeding rate (ABR) for all bleeding episodes by type of bleed; Annualized bleeding rate (ABR) for all blee...
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.