Russian Kogenate Pediatric Study

Phase 4

Completed

• Conditions: Hemophilia A
• Interventions: Drug: rFVIII-FS (Kogenate FS, BAY14-2222) 70 IU/kg, dosing once per week; Drug: rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg twice per week (30 IU/kg + 40 IU/kg); Drug: rFVIII-FS (Kogenate FS, BAY14-2222) 75 IU/kg, dosing three times per week (3 x 25 IU/kg)

• Registration Number: NCT00632814
• Lead Sponsor: Bayer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2008-03-04
• Study First Submitted QC: 2008-03-10
• Study First Posted: 2008-03-11
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Results First Submitted: 2011-01-14
• Results First Submitted QC: 2011-01-14
• Results First Posted: 2011-02-08
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-04
• Last Update Posted: 2015-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 32

Inclusion Criteria

• Male
• Severe hemophilia A or moderate hemophilia A
• 1-12 years of age
• Requiring treatment with FVIII

Read More

Exclusion Criteria

• Current or prior inhibitor or familial antecedents of inhibitor
• Surgery required during the study (9 months)
• Positive for HIV

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw	rFVIII-FS (Kogenate FS, BAY14-2222) 70 IU/kg, dosing once per week	rFVIII-FS (Octocog-alfa, antihemophilic factor \[recombinant\]) 70 IU/kg, dosing by injection once per week \[qw\] (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), biw (30 IU/kg + 40 IU/kg)	rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg twice per week (30 IU/kg + 40 IU/kg)	rFVIII-FS (Octocog-alfa, antihemophilic factor \[recombinant\]) 70 IU/kg, dosing by injection twice per week \[biw\] (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), tiw (3 x 25 IU/kg)	rFVIII-FS (Kogenate FS, BAY14-2222) 75 IU/kg, dosing three times per week (3 x 25 IU/kg)	rFVIII-FS (Octocog-alfa, antihemophilic factor \[recombinant\]) 75 IU/kg, dosing by injection three times per week \[tiw\] (3 x 25 IU/kg \[day 1, 3, 5\]) for 9 months. No escalation opportunity for participants in this group

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Less Than 2 Joint Bleeds During the 9-month Treatment Period	Up to 9 months

Secondary Outcome Measures

Name	Time	Method
Number of Bleeds Per Participant During the 9-month Treatment Period	Up to 9 months
Number of Participants With Bleeding Events During the 9-month Treatment Period	Up to 9 months
Number of Participants With Joint Bleeds During the 9-month Treatment Period	Up to 9 months
Number of Participants in Each Group at the End of the Study	Up to 9 months
Actual Monthly rFVIII-FS Consumption	Up to 9 months
Change From Baseline in Stockholm Hemophilia Joint Score at 9 Months of Treatment	baseline and 9 months	The assessment of joint function using Stockholm Joint Score. The minimum value is 0 (the best condition), and the maximum value is 140 (the worst condition).
Haemo-QoL Standardized Total Score at 9 Months of Treatment (Completed by Participants in the Total Group)	9 months	Quality of life (QoL) was measured by the Haemo-QoL standardized total Score, which ranged from 0 (the best condition) to 100 (the worst condition).
Haemo-QoL Standardized Total Score (Completed by Parents/Caregivers in the Total Group) at 9 Months of Treatment	9 months	Quality of life (QoL) was measured by the Haemo-QoL standardized total Score, which ranged from 0 (the best condition) to 100 (the worst condition).