Phase 4 Haemophilia Trial, Recruiting NCT06145373 Sponsor: Sanofi Condition: Haemophilia
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Phase 4 Haemophilia Trial, Recruiting

NCT06145373
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 are male and aged 12 years or older at the time of signing the consent form
  • You have been diagnosed with severe congenital hemophilia A, meaning your body produces less than 1% of the normal level of clotting factor VIII, confirmed by a lab test or medical records
  • You have a history of inhibitors (antibodies that block hemophilia treatment), shown by specific blood test results or past medical records showing an immune response to treatment (confirm with trial site)
  • You are currently taking the full prescribed dose of emicizumab as a preventive treatment, regardless of whether you have inhibitors or not
  • You have read, understood, and signed the consent form agreeing to follow the trial's requirements

Who may not be able to join:

  • You have another condition that affects bleeding or blood clotting
  • You have a history of antiphospholipid antibody syndrome (a disorder where the immune system mistakenly attacks certain proteins in the blood)
  • You have had a blood clot in an artery or vein, an irregular heartbeat (atrial fibrillation), significant heart valve problems, a heart attack, chest pain (angina), a mini-stroke, or a stroke — though clots related to a medical line or port may not disqualify you (confirm with trial site)
  • You have a significant liver disease
  • You have previously taken part in a trial involving a drug called fitusiran
  • You have previously taken part in a gene therapy trial
  • Your antithrombin activity level (a protein involved in blood clotting) is below 60% on your screening blood test (confirm with trial site)
  • You have a hereditary or acquired condition that increases your risk of blood clots
  • You have a hepatitis C infection, unless your virus levels are undetectable and you do not have liver scarring (cirrhosis)
  • You currently have an acute hepatitis A or hepatitis E infection
  • You have an active hepatitis B infection
  • You are HIV positive with a very low immune cell count (fewer than 200 CD4 cells per microlitre of blood)
  • You have reduced kidney function

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 28 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: Clinical Sciences & Operations, Sanofi

Phone: 800-633-1610

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
Registry
ClinicalTrials.gov
Start date
1 March 2024
Est. completion
28 May 2028

Where this trial is recruiting

🇹🇼 Taiwan 🇺🇸 United States

Primary endpoints

Number of participants with Adverse events (AEs) during the fitusiran treatment

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: 28 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