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Phase 4 N=30 Treatment

Prophylaxis Versus on Demand Treatment for Children With Hemophilia A

Hemophilia A

Bottom Line

View on ClinicalTrials.gov: NCT01810666 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jan 2015
Primary outcome: Primary: Difference of Annualized Number of All Bleeds Between On-demand and Prophylaxis Period — 56.00 Bleeds

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Recombinant Factor VIII (Kogenate FS, BAY14-2222) (Biological)
Age
Pediatric · 2+ yrs
Sex
Male
Sponsor
Bayer
Primary completion
Jan 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Difference of Annualized Number of All Bleeds Between On-demand and Prophylaxis Period		 56.00 —
SECONDARY
Difference of Annualized Number of Joint Bleeds Between On-demand and Prophylaxis Period		 37.71 —
SECONDARY
Difference of Intra-individual Change of Joint Function During Each Period Assessed by the Hemophilia Joint Health Score Between On-demand and Prophylaxis Period		 -3.00 —

Summary

Comparison of the effect of three times a week prophylaxis on all bleeds with on-demand treatment for children with severe Hemophilia A.

Eligibility Criteria

Inclusion Criteria

  • Male, aged 2-16yrs
  • Severe hemophilia A (<1% FVIII: C [Blood Clotting Factor VIII:C] )
  • Minimum of at least 50 documented ED (exposure day) prior to enrolment
  • No measurable inhibitor activity at baseline and history of FVIII inhibitor antibody formation
  • Parents or legal guardians document, sign, and date informed consent

Exclusion Criteria

  • Another bleeding disease that is different from hemophilia A
  • Known hypersensitivity to the active substance, mouse or hamster protein
  • Thrombocytopenia (platelet count <100 000/mm3) based on previous medical records
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01810666). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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