Trial Condition(s):
Hemophilia A
Russian Kogenate Pediatric Study
Bayer Identifier:
12684
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Izamaylovska Children's Hospital Moscow, Russia, 105077 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Children's Center of Oncology and Hematology Ekaterinburg, Russia, 620149 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hemophilia Centre St. Petersburg, Russia, 191186 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Scientific Research Institute of hematology and blood tranf. Kirov, Russia, 610 027 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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 Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
3
Primary Outcome
- Percentage of participants with less than 2 joint bleeds during the 9-month treatment periodTimeframe: Up to 9 months
Secondary Outcome
- Number of bleeds per participant during the 9-month treatment periodTimeframe: Up to 9 months
- Number of participants with bleeding events during the 9-month treatment periodTimeframe: Up to 9 months
- Number of participants with joint bleeds during the 9-month treatment periodTimeframe: Up to 9 months
- Number of participants in each group at the end of the studyTimeframe: Up to 9 months
- Actual monthly rFVIII-FS consumptionTimeframe: Up to 9 months
- Change from baseline in Stockholm Hemophilia Joint Score at 9 months of treatmentTimeframe: baseline and 9 months
- Haemo-QoL standardized total Score at 9 months of treatment (completed by participants in the total group)Timeframe: 9 months
- Haemo-QoL standardized total Score (completed by parents/caregivers in the total group) at 9 months of treatmentTimeframe: 9 months
Additional Information
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