Phase 4 Haemophilia Trial, Recruiting NCT05935358 Sponsor: Octapharma Condition: Haemophilia
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Phase 4 Haemophilia Trial, Recruiting

NCT05935358
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:

  • People who have severe haemophilia A, meaning their Factor VIII (a blood clotting protein) level is less than 1% of normal, based on their medical history
  • People who are male and at least 12 years old
  • People who have previously been treated with a Factor VIII product on at least 150 separate occasions
  • People who have been on a regular preventative treatment programme using emicizumab for at least 1 month before a planned major surgery that will require Factor VIII treatment
  • People (or their parent or legal guardian, if applicable) who are willing and able to provide written consent to participate, in line with local rules

Who may not be able to join:

  • People who have a blood clotting disorder other than haemophilia A
  • People who have ever developed antibodies (called inhibitors) that work against Factor VIII treatment, at a level of 0.6 Bethesda units or higher, based on their medical history
  • People with severe liver or kidney disease, as shown by certain abnormal blood test results (confirm with trial site)
  • People who have a known allergy or sensitivity to the study drug Nuwiq or any of its ingredients, including sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate, or poloxamer 188
  • People who have already had surgery as part of this study
  • People who are currently taking part in another clinical trial that involves a treatment intervention
  • People who have received any experimental or investigational medication within the 30 days before their screening visit

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: Shveta Gupta, MD, Arnold Palmer Hospital for Children

Phone: +41 554512141

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
Octapharma
Registry
ClinicalTrials.gov
Start date
28 November 2023
Est. completion
1 August 2026

Where this trial is recruiting

🇭🇷 Croatia 🇫🇮 Finland 🇫🇷 France 🇩🇪 Germany 🇮🇳 India 🇮🇹 Italy North Macedonia 🇷🇸 Serbia 🇪🇸 Spain 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Overall haemostatic efficacy

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