CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 30 enrolled
Drug / intervention
Recombinant Factor VIII (Kogenate FS, BAY14-2222)biological
Likely dose
Recombinant Factor VIII (Kogenate FS, BAY14-2222) 25 IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01810666
NCT01810666Phase 4Completed
CompareCT.gov

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

Bayer·interventional·Posted Mar 13, 2013·Updated May 19, 2015

In Brief

A Phase 4 clinical trial evaluating Recombinant Factor VIII (Kogenate FS, BAY14-2222) for Hemophilia A. Completed, enrolled 30 participants across 5 sites.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia A
CountriesChina
Collaborators--

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 13, 2013
Enrollment StartMar 1, 2013
Primary CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 13.3 years ago

Interventions

Recombinant Factor VIII (Kogenate FS, BAY14-2222)biological

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.