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Clinical Trial Summary

The purpose of this study is to assess the effect of a new risk score approach based on participant's phenotypic and biologic variables to determine the most appropriate prophylaxis regimen for adolescent/adult (≥ 12 years) PTPs with congenital hemophilia A who switch from a SHL FVIII prophylaxis to an EHL product (Jivi). All eligible participants will be assigned a risk score at baseline and will start treatment 2x/week (40 IU/kg/dose) with Jivi for 4 weeks. Treatment will then continue based on their assignment to 1 of the 3 following prophylaxis regimens: - Participants with a high risk score (> 4) continue on prophylaxis 2x/week (40 IU/kg/dose) - Participants with a medium risk score (2 to 4) will switch after 4 weeks to prophylaxis Q5D (50 IU/kg/dose) - Participants with a low risk score (< 2) will switch after 4 weeks to prophylaxis Q5D (50 IU/kg/dose) and then after 4 weeks to a less frequent (e.g. Q7D) regimen (60 IU/kg/dose)

Clinical Trial Description


Study Design

Related Conditions & MeSH terms

NCT number NCT05036278
Study type Interventional
Source Bayer
Contact Bayer Clinical Trials Contact
Phone (+)1-888-84 22937
Email [email protected]
Status Not yet recruiting
Phase Phase 4
Start date November 22, 2021
Completion date February 6, 2023

See also
  Status Clinical Trial Phase
Completed NCT02093897 - Pharmacokinetic, Efficacy, and Safety Study of Recombinant Factor VIII Single Chain (rVIII-SingleChain) in Children With Severe Hemophilia A Phase 3