Russian Kogenate Pediatric Study
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.
2 other identifiers
interventional
32
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jun 2007
Typical duration for phase_4
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 4, 2008
CompletedFirst Posted
Study publicly available on registry
March 11, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedResults Posted
Study results publicly available
February 8, 2011
CompletedJuly 1, 2015
June 1, 2015
2.3 years
March 4, 2008
January 14, 2011
June 4, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Less Than 2 Joint Bleeds During the 9-month Treatment Period
Up to 9 months
Secondary Outcomes (8)
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
- +3 more secondary outcomes
Study Arms (3)
rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw
EXPERIMENTALrFVIII-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)
EXPERIMENTALrFVIII-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)
EXPERIMENTALrFVIII-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
Interventions
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 (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 (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
Eligibility Criteria
You may qualify if:
- Male
- Severe hemophilia A or moderate hemophilia A
- years of age
- Requiring treatment with FVIII
You may not qualify if:
- Current or prior inhibitor or familial antecedents of inhibitor
- Surgery required during the study (9 months)
- Positive for HIV
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (4)
Unknown Facility
Kirov, 610 027, Russia
Unknown Facility
Moscow, 105077, Russia
Unknown Facility
Saint Petersburg, 191186, Russia
Unknown Facility
Yekaterinburg, 620149, Russia
Related 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 Population with Moderate/Severe Hemophilia A. Journal of Coagulation Disorders 2011; 3:(1). October 2011
RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Protocol deviations were not excluded: e.g. a previously untreated patient developed the transitory inhibitor; change to a higher group did not always occur according protocol; there was temporary lack of smaller vial sizes at the centers.
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- BAYER
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2008
First Posted
March 11, 2008
Study Start
June 1, 2007
Primary Completion
September 1, 2009
Study Completion
September 1, 2009
Last Updated
July 1, 2015
Results First Posted
February 8, 2011
Record last verified: 2015-06