check_circleStudy Completed
Hemophilia A
Bayer Identifier:
12684
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Russian Kogenate Pediatric Study
Trial purpose
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.
Key Participants Requirements
Sex
MaleAge
1 - 12 YearsTrial summary
Enrollment Goal
32Trial Dates
June 2007 - September 2009Phase
Phase 4Could I Receive a placebo
NoProducts
Kogenate FS (Recombinant Factor VIII, BAY14-2222)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Izamaylovska Children's Hospital | Moscow, 105077, Russia |
Completed | Children's Center of Oncology and Hematology | Ekaterinburg, 620149, Russia |
Completed | Hemophilia Centre | St. Petersburg, 191186, Russia |
Completed | Scientific Research Institute of hematology and blood tranf. | Kirov, 610 027, Russia |
Primary Outcome
- Percentage of participants with less than 2 joint bleeds during the 9-month treatment perioddate_rangeTime Frame:Up to 9 monthsenhanced_encryptionyesSafety Issue:
Secondary Outcome
- Number of bleeds per participant during the 9-month treatment perioddate_rangeTime Frame:Up to 9 monthsenhanced_encryptionyesSafety Issue:
- Number of participants with bleeding events during the 9-month treatment perioddate_rangeTime Frame:Up to 9 monthsenhanced_encryptionyesSafety Issue:
- Number of participants with joint bleeds during the 9-month treatment perioddate_rangeTime Frame:Up to 9 monthsenhanced_encryptionyesSafety Issue:
- Number of participants in each group at the end of the studydate_rangeTime Frame:Up to 9 monthsenhanced_encryptionNoSafety Issue:
- Actual monthly rFVIII-FS consumptiondate_rangeTime Frame:Up to 9 monthsenhanced_encryptionNoSafety Issue:
- Change from baseline in Stockholm Hemophilia Joint Score at 9 months of treatmentdate_rangeTime Frame:baseline and 9 monthsenhanced_encryptionNoSafety Issue:
- Haemo-QoL standardized total Score at 9 months of treatment (completed by participants in the total group)date_rangeTime Frame:9 monthsenhanced_encryptionNoSafety Issue:
- Haemo-QoL standardized total Score (completed by parents/caregivers in the total group) at 9 months of treatmentdate_rangeTime Frame:9 monthsenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
Non-randomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
3Additional Information
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