Trial Condition(s):

Hemophilia A

Russian Kogenate Pediatric Study

Bayer Identifier:

12684

ClinicalTrials.gov Identifier:

NCT00632814

EudraCT Number:

2014-005253-39

Study Completed

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
32
Trial Dates
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Phase
4
Could I receive a placebo?
No
Products
Kogenate FS (Recombinant Factor VIII, BAY14-2222)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Izamaylovska Children's Hospital

Moscow, Russia, 105077

Status
Completed
 
Locations

Children's Center of Oncology and Hematology

Ekaterinburg, Russia, 620149

Status
Completed
 
Locations

Hemophilia Centre

St. Petersburg, Russia, 191186

Status
Completed
 
Locations

Scientific Research Institute of hematology and blood tranf.

Kirov, Russia, 610 027

Status
Completed
 

Trial Design