CompletedPhase 4

Russian Kogenate Pediatric Study

Russia32 participantsStarted 2007-06

Plain-language 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.

Who can participate

Age range1 Year – 12 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Percentage of Participants With Less Than 2 Joint Bleeds During the 9-month Treatment Period

Timeframe: Up to 9 months

Trial details

NCT IDNCT00632814

SponsorBayer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-09

Results submitted2011-01-14

View on ClinicalTrials.gov More Hemophilia A trials