Haemophilia Trial, Recruiting NCT04023019 Sponsor: Emory University Condition: Haemophilia
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Haemophilia Trial, Recruiting

NCT04023019
Recruiting Not Applicable

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:

  • Male people diagnosed with haemophilia A of any level of severity, who have had a history of inhibitor levels of 0.6 BU/mL or higher — including those whose previous immune tolerance induction (ITI) treatment did not work (confirm with trial site for exact inhibitor measurement details)
  • People currently undergoing a specific type of treatment called immune tolerance induction (ITI) using one of three products — Nuwiq, octanate, or wilate — whether on their own or combined with one of the following additional therapies: emicizumab, activated prothrombin complex concentrate (aPCC), or activated recombinant factor VII (rFVIIa)
  • People who are able to give signed consent to participate, or — for younger participants — whose parent or legal guardian is able to give that consent on their behalf

Who may not be able to join:

  • People who have been diagnosed with any blood clotting disorder other than haemophilia A
  • People whose participation would be partly based on past medical records, where detailed records of treatment, all bleeding episodes, inhibitor levels, and factor VIII levels are not available for that past period

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 26 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Robert Sidonio, MD, MSc, Emory University

Phone: 404-785-1637

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
Not Applicable
Registry
ClinicalTrials.gov
Start date
17 March 2020
Est. completion
1 December 2028

Where this trial is recruiting

🇩🇪 Germany 🇺🇸 United States

Primary endpoints

Proportion of participants achieving inhibitor titer < 0.6 Bethesda units (BU)/mL L for at least 2 consecutive measurements; Proportion of participants achieving FVIII recovery ≥ 66% of the predefined reference value of 1.5% IU/kg body weight (Groups 1 and 2); Proportion of participants achieving FVIII half-life ≥ 6 h (Groups 1 and 2); Annualized bleeding rate

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: 26 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