Survey on the success of individualized treatment for haemophilia A

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 program evaluates the success of immune tolerance induction (ITI) in 300 patients with haemophilia A who have developed inhibitors against factor VIII. The study focuses on high-dose treatment based on individualized concentrate selection to improve management of this complication. It also investigates the role of various in vitro tests in predicting ITI success rates. Data will be systematically documented and analyzed to enhance understanding of treatment efficacy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Based on the decision of the treating physicians in the participating centres, male patients at any age suffering from severe (FVIII activity \< 1%), moderate (FVIII activity \>1% - 5%), or mild (FVIII activity \> 5%) haemophilia A will be included into this post marketing observation if relevant inhibitor levels (\> 0.6 BU) have been detected, or - in case of an inhibitor level \<0.6 BU - with reduced recovery or half-life of FVIII.
* The observation is also open for patients who failed an earlier ITI attempt.

Exclusion Criteria:

* Female

Where it's running

• Haemophilia Centre Rhine Main
  Frankfurt am Main, Hesse, Germany Recruiting

Study contacts

• Principal investigator: Carmen Escuriola Ettingshausen, MD — Director HZRM
• Study coordinator: Carmen Escuriola Ettingshausen, MD
• Email: carmen.escuriola@hzrm.de
• Phone: +49 (0) 15115511159

Similar studies

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

• Denecimig (Mim8) for adults with acquired Haemophilia A

  This study tests whether denecimig can be safe and helpful for adults newly diagnosed with acquired Haemophilia A.

  Recruiting Phase 3 Novo Nordisk A/S · Iowa City, Iowa and 82 other locations · NCT07830732

• Surgical Use of Efanoctocog alfa in Hemophilia A Patients

  This observational study looks at how efanesoctocog alfa (Altuvoct) is used around surgery in people with hemophilia A to see if it helps control bleeding.

  Recruiting Hospices Civils de Lyon · Bron · NCT07723560

• SCT800 for preventing and treating bleeds in previously untreated severe hemophilia A patients

  This test tries SCT800, a recombinant factor VIII, as regular prevention and to treat bleeds in male patients with severe hemophilia A who haven't had prior factor VIII treatment.

  Recruiting Phase 3 Sinocelltech Ltd. · Beijing, Beijing Municipality · NCT07437404

• Different doses of Inno8 for adults with haemophilia A.

  This trial will test different doses of the experimental medicine Inno8 in adults with haemophilia A to see if it is safe and how the body handles it.

  Recruiting at 25 sites Phase 1 Novo Nordisk A/S · Aurora, Colorado and 32 other locations · NCT07220564

• Evaluating synovitis in adults with haemophilia A

  This study looks at how often adults with hemophilia A experience joint inflammation caused by bleeding and how it affects their joint health.

  Recruiting University Hospital, Bonn · Bonn, North Rhine-Westphalia · NCT06352216

• Evaluating the effectiveness and safety of FVIII concentrates in young haemophilia A patients

  This study is testing how well and safely a new treatment for hemophilia A works in young children who haven't had much treatment before.

  Recruiting at 33 sites Octapharma · Miami, Florida and 58 other locations · NCT03695978

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.