Status:
COMPLETED
A Study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Patients Under the Age of 6 Years
Lead Sponsor:
Bio Products Laboratory
Conditions:
Haemophilia B
Eligibility:
All Genders
Up to 6 years
Phase:
PHASE3
Brief Summary
The objective of this study was to assess the safety and efficacy of Replenine®-VF in children enrolled in the study, under the age of six years, with severe haemophilia B.
Eligibility Criteria
Inclusion
- Patients under six years of age at the time of entry with severe Haemophilia B at the time of diagnosis without inhibitors to FIX and requiring Factor IX therapy.
Exclusion
- \-
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02263469
Start Date
August 1 2005
Last Update
October 13 2014
Active Locations (4)
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1
Samodzielny Publiczny Dzieciecy Szpital Kliniczny, Oddzial Pediatrii, Hematologii I Onkologii, ul. Marszalkowska 24, 00-576
Warsaw, Poland
2
Institute of Urgent and Recovery Surgery, Academy of Medical Science of Ukraine, Leninski Avenue
Donetsk, Ukraine, 83045
3
Institute of Haematology and Transfusiology, Academy of Medical Science of Ukrainem Berlynskogo Str.
Kiev, Ukraine
4
Institute of Blood Pathology and Transfusion Medicine, Academy of Medical Science of Ukraine, Gen. Chuprynkea Str.
Lviv, Ukraine, 79044