CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 32 enrolled
Drug / intervention
rFVIII-FS (Kogenate FS, BAY14-2222) 70 IU/kg, dosing once per week +2 moredrug
Likely dose
rFVIII-FS (Kogenate FS, BAY14-2222) 70 IU/kg, dosing once per weekfrom 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/NCT00632814
NCT00632814Phase 4Completed
CompareCT.gov

A Prospective Study to Evaluate the Effect of rFVIII-FS in Different Prophylactic Regimens on Bleeding Events Frequency and Development of Arthropathy in Previously Treated and Minimally Treated Hemophilia A Pediatric Population.

Bayer·interventional·Posted Mar 11, 2008·Updated Jul 1, 2015

In Brief

A Phase 4 clinical trial evaluating rFVIII-FS (Kogenate FS, BAY14-2222) 70 IU/kg, dosing once per week, rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg twice per week (30 IU/kg + 40 IU/kg), and 1 other intervention for Hemophilia A. Completed, enrolled 32 participants across 4 sites.

Detailed Summary

A prospective study to evaluate the effect of rFVIII-FS in different prophylactic regimens on bleeding events frequency and development of arthropathy in Previously Treated and Minimally treated Hemophilia A pediatric population.

Study Details

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

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 11, 2008
Enrollment StartJun 1, 2007
Primary CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 18.3 years ago

Interventions

rFVIII-FS (Kogenate FS, BAY14-2222) 70 IU/kg, dosing once per weekdrug

rFVIII-FS (Octocog-alfa, antihemophilic factor \[recombinant\]) 70 IU/kg, dosing by injection once per week (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)

rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg twice per week (30 IU/kg + 40 IU/kg)drug

rFVIII-FS (Octocog-alfa, antihemophilic factor \[recombinant\]) 70 IU/kg, dosing by injection twice per week (30 IU/kg \[day 1\] + 40 IU/kg \[day 4\]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)

rFVIII-FS (Kogenate FS, BAY14-2222) 75 IU/kg, dosing three times per week (3 x 25 IU/kg)drug

rFVIII-FS (Octocog-alfa, antihemophilic factor \[recombinant\]) 75 IU/kg, dosing by injection three times per week (3 x 25 IU/kg \[day 1, 3, 5\]) for 9 months. No escalation opportunity for patients in this group