Phase 4 Completed N=30 Treatment

Prophylaxis Versus on Demand Treatment for Children With Hemophilia A

Source: ClinicalTrials.gov NCT01810666 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2015

Primary outcomePrimary: Difference of Annualized Number of All Bleeds Between On-demand and Prophylaxis Period — 56.00 Bleeds

Summary

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

Outcome Measures

Outcome	Result	p-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	—

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. Informational only — not medical advice.