Clinical Trials Directory

Trials / Completed

CompletedNCT01810666

Prophylaxis Versus on Demand Treatment for Children With Hemophilia A

Routine Prophylaxis Treatment Versus On-demand Treatment for Children With Severe Hemophilia A: Comparison of All Bleeding Events in Chinese Hemophilia Patients

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
30 (actual)
Sponsor
Bayer · Industry
Sex
Male
Age
2 Years – 16 Years
Healthy volunteers
Not accepted

Summary

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

Conditions

Interventions

TypeNameDescription
BIOLOGICALRecombinant Factor VIII (Kogenate FS, BAY14-2222)Participants received Recombinant Factor VIII (Rec. factor VIII) on-demand treatment for 12 weeks followed by a 12 weeks prophylaxis treatment phase. The dose and mode of prophylaxis treatment was 25 IU/Kg, 3 times/per week. The dose in on-demand treatment was decided by physician according to the package insert or the current standard of care.

Timeline

Start date
2013-03-01
Primary completion
2014-01-01
Completion
2014-01-01
First posted
2013-03-13
Last updated
2015-05-19
Results posted
2015-01-05

Locations

5 sites across 1 country: China

Source: ClinicalTrials.gov record NCT01810666. Inclusion in this directory is not an endorsement.