Phase 3 Haemophilia Trial, Recruiting NCT04563520 Sponsor: Emory University Condition: Haemophilia
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Phase 3 Haemophilia Trial, Recruiting

NCT04563520
Recruiting Phase 3

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 moderately severe Hemophilia A, meaning your body produces very low levels of a clotting protein called Factor VIII
  • You are 6 years old or older at the time of signing up for the trial
  • You have been tested on 2 separate occasions and shown to have a high level of "inhibitors" (antibodies that block clotting treatment), with both tests done within the last 2 years
  • You or your parent/guardian has agreed to take part and signed a consent form
  • Your blood counts (red blood cells and platelets) are at an acceptable level based on a blood test
  • Your liver is functioning well enough, based on blood test results (confirm with trial site)
  • Your kidneys are functioning well enough, based on blood test results (confirm with trial site)

Who may not be able to join:

  • You have another bleeding disorder in addition to Hemophilia A (some exceptions may apply — confirm with trial site)
  • You were actively bleeding and needed clotting factor treatment at the time of your screening appointment
  • You have had, or currently have, blood clot problems (with some exceptions for previously resolved clots from medical lines)
  • You had surgery within 14 days before your screening appointment
  • You have a condition that may raise your risk of bleeding or blood clots
  • You were treated with certain clotting medications (rFVIIa or aPCC) within 7 days before screening
  • You have had a significant allergic reaction to a monoclonal antibody therapy or to any ingredient in the study drug (emicizumab)
  • You are currently taking any other medication (besides emicizumab) that could affect how your blood clots
  • You have HIV with a low immune cell count (below 200 CD4 cells), if you are 35 years of age or older
  • You are currently taking, or plan to take, medications that affect your immune system during the study
  • You are considered at high risk for a condition called TMA (a serious condition affecting blood and organs — confirm with trial site)
  • You have another illness, treatment, or abnormal test result that the trial doctor believes could make it unsafe for you to participate

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 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Robert Sidonio, MD, 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
Phase 3
Registry
ClinicalTrials.gov
Start date
1 June 2026
Est. completion
1 March 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Thrombin generation capacity after aPCC (FEIBA) infusion

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