Observing treatment approaches for Hemophilia A patients with inhibitors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on male patients with Hemophilia A who have developed inhibitors to factor VIII. It aims to document various management strategies, including immune tolerance induction and the use of bypassing agents. Participants will be categorized into treatment groups based on their current therapies and may switch groups if their treatment changes. The study will follow participants for up to five years to evaluate the efficacy and safety of these approaches.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male persons with haemophilia A, of any severity, who have a historical inhibitor titer ≥ 0.6 BU/mL, including those who have failed previous immune tolerance induction (ITI) attempt(s)
* Persons undergoing ITI with Nuwiq, octanate, or wilateor undergoing ITI with Nuwiq®, octanate® or wilate® and receiving prophylactic therapy with emicizumab, activated prothrombin complex concentrate (aPCC), or activated recombinant factor VII (rFVIIa)
* Participants or participants' parent(s)/legal guardian(s) must be capable of giving signed informed consent and be able to understand the trial documents

Exclusion Criteria:

* Participants are excluded from the trial if any coagulation disorder other than haemophilia A is diagnosed
* Partly retrospective patients will be excluded if detailed documentation on treatment, all bleeding episodes, inhibitor titers, and FVIII levels is not available for the retrospective period

Where it's running

• Arthur M. Blank Hospital
  Atlanta, Georgia, United States Recruiting
• HZRM Hämophilie-Zentrum Rhein Main
  Mörfelden-Walldorf, Germany Recruiting

Study contacts

• Principal investigator: Robert Sidonio, MD, MSc — Emory University
• Study coordinator: Robert Sidonio, MD, MSc
• Email: robert.sidonio.jr@emory.edu
• Phone: 404-785-1637

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• NXT007 versus emicizumab to prevent bleeds in people with Hemophilia A

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.