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NCT00632814 Clinical Trial

Russian Kogenate Pediatric Study

Hemophilia A Clinical Trial

Official title:
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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00632814
Other study ID # 12684
Secondary ID 2014-005253-39
Status Completed
Phase Phase 4
First received March 4, 2008
Last updated June 4, 2015
Start date June 2007
Est. completion date September 2009

Study information
Verified date June 2015
Source Bayer
Contact n/a
Is FDA regulated No
Health authority Russia: Ministry of Health of the Russian Federation
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 32
Est. completion date September 2009
Est. primary completion date September 2009
Accepts healthy volunteers No
Gender Male
Age group 1 Year to 12 Years
Eligibility Inclusion Criteria:

- Male

- Severe hemophilia A or moderate hemophilia A

- 1-12 years of age

- Requiring treatment with FVIII

Exclusion Criteria:

- Current or prior inhibitor or familial antecedents of inhibitor

- Surgery required during the study (9 months)

- Positive for HIV

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• 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 (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)
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)
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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

Russian Federation, 

References & Publications (1)

V.V. Vdovin, T.A. Andreeva, T.A. Chernova, F.G. Perina, E.E.M. Shiller, P.V. Svirin, M. Maas Enriquez, and S. Rauchensteiner. Prophylaxis with Once, Twice or Three-Times Weekly Dosing of rFVIII-FS Prevents Joint Bleeds in a Previously Treated Pediatric Po

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Less Than 2 Joint Bleeds During the 9-month Treatment Period Up to 9 months Yes
Secondary Number of Bleeds Per Participant During the 9-month Treatment Period Up to 9 months Yes
Secondary Number of Participants With Bleeding Events During the 9-month Treatment Period Up to 9 months Yes
Secondary Number of Participants With Joint Bleeds During the 9-month Treatment Period Up to 9 months Yes
Secondary Number of Participants in Each Group at the End of the Study Up to 9 months No
Secondary Actual Monthly rFVIII-FS Consumption Up to 9 months No
Secondary Change From Baseline in Stockholm Hemophilia Joint Score at 9 Months of Treatment 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). baseline and 9 months No
Secondary Haemo-QoL Standardized Total Score at 9 Months of Treatment (Completed by Participants in the Total Group) 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). 9 months No
Secondary Haemo-QoL Standardized Total Score (Completed by Parents/Caregivers in the Total Group) at 9 Months of Treatment 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). 9 months No
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