Damoctocog alfa pegol in previously treated children with Hemophilia 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 study collects information from routine care to understand how damoctocog alfa pegol performs in children with Hemophilia A. Participants are 7 to under 12 years old and are on regular prophylaxis with damoctocog alfa pegol, with prior exposure to FVIII products. Data come from medical records and ongoing treatment, without any changes to care for the study. The study aims to describe safety and effectiveness in a real-world setting over approximately one year. Key eligibility includes previous FVIII exposure, absence of current FVIII inhibitors, and consent from guardians and assent from the child.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosis of hemophilia A
* Patients must be 7 to \< 12 years of age at enrollment
* Patients previously treated for hemophilia A ((≥50 exposure days to FVIII)
* No current evidence of FVIII inhibitor or clinical suspicion of FVIII inhibitor
* Patients without a previous history of inhibitors or patients with a previous history of inhibitors on standard prophylaxis therapy for at least 1 year prior to study entry
* Initiation of prescription or currently prescribed damoctocog alfa pegol for regular continuous prophylaxis (intent to treat for 52 weeks/year)
* Signed informed consent/assent.

Exclusion Criteria:

* Presence of a FVIII inhibitor
* Concurrent participation in an investigational program with interventions outside of routine clinical practice
* Diagnosis of any other bleeding/coagulation disorder other than hemophilia A
* Use of another hemostatic agent as the primary method of bleeding prophylaxis during the observation period
* Contra-indications according to the local marketing authorization
* Current immune tolerance induction (ITI) treatment for a FVIII inhibitor

Where it's running

• Many locations
  Many Locations, Lithuania Recruiting
• Loma Linda University Health
  Loma Linda, California, United States Not yet recruiting
• Rutgers, The State University
  New Brunswick, New Jersey, United States Not yet recruiting
• Many locations
  Many Locations, Brazil Not yet recruiting
• Many locations
  Many Locations, Canada Not yet recruiting
• Many locations
  Many Locations, Colombia Not yet recruiting

Study contacts

• Study coordinator: Bayer Clinical Trials Contact
• Email: clinical-trials-contact@bayer.com
• Phone: (+)1-888-84 22937

Similar studies

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

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• SR604: a new treatment tested in adults with Hemophilia A/B or congenital Factor VII deficiency

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

  This will test whether NXT007 prevents bleeding better than emicizumab in people aged 12 and older with Hemophilia A, including those with or without factor VIII inhibitors.

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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.