Phase 4 Haemophilia Trial, Recruiting NCT06940830 Sponsor: Swedish Orphan Biovitrum Condition: Haemophilia
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Phase 4 Haemophilia Trial, Recruiting

NCT06940830
Recruiting Phase 4

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 have been diagnosed with haemophilia A.
  • You are able to read, understand, and sign a consent form agreeing to take part in the study.
  • You have been prescribed a specific haemophilia medicine called efanesoctocog alfa as a regular preventive treatment, either within the 6 months before joining the study or at the time of joining.
  • You have been on some form of regular preventive haemophilia treatment for at least 12 months before being switched to efanesoctocog alfa.
  • There are written records available showing your haemophilia treatments and any bleeding episodes during the 12 months before you were switched to efanesoctocog alfa and up until you join the study.
  • You are willing to attend scheduled study visits and complete required health assessments, including joint health checks and questionnaires.
  • You (or your legal guardian) are willing and able to keep a record of any bleeding episodes and any treatments used for those bleeds.
  • If you are in a specific part of the study called HEAD-US: you agree to have yearly ultrasound scans on certain joints (ankles, elbows, and knees).

Who may not be able to join:

  • You have a form of haemophilia A that was not inherited (acquired haemophilia A), or you have a different type of blood clotting disorder.
  • Your medical records show that your body has developed antibodies (called inhibitors) that block the haemophilia treatment, at any point between starting efanesoctocog alfa and joining the study.
  • You are currently taking part in another clinical trial, or you have taken an experimental medicine (including for haemophilia) within the 3 months before joining this study.
  • The study doctor decides, for any reason, that taking part would not be appropriate 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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Study Physician, Swedish Orphan Biovitrum AB (publ)

Phone: +46 08-697-20 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

Status
Recruiting
Phase
Phase 4
Sponsor
Swedish Orphan Biovitrum
Registry
ClinicalTrials.gov
Start date
21 May 2025
Est. completion
1 December 2028

Where this trial is recruiting

🇭🇷 Croatia 🇨🇿 Czechia 🇫🇷 France 🇩🇪 Germany 🇮🇪 Ireland 🇮🇹 Italy 🇪🇸 Spain 🇬🇧 United Kingdom

Primary endpoints

Annualized joint bleeding rate (AjBR) over the prospective observation period.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov