A Study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Patients Under the Age of 6 Years
Phase 3
Completed
- Conditions
- Haemophilia B
- Interventions
- Biological: Replenine®-VF (High Purity Factor IX)
- Registration Number
- NCT02263469
- Lead Sponsor
- Bio Products Laboratory
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- 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 Criteria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Replenine®-VF Replenine®-VF (High Purity Factor IX) -
- Primary Outcome Measures
Name Time Method Amount of Factor IX Administered per Month (IU/KG) 26 Weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Samodzielny Publiczny Dzieciecy Szpital Kliniczny, Oddzial Pediatrii, Hematologii I Onkologii, ul. Marszalkowska 24, 00-576
🇵🇱Warsaw, Poland
Institute of Urgent and Recovery Surgery, Academy of Medical Science of Ukraine, Leninski Avenue
🇺🇦Donetsk, Ukraine
Institute of Haematology and Transfusiology, Academy of Medical Science of Ukrainem Berlynskogo Str.
🇺🇦Kiev, Ukraine
Institute of Blood Pathology and Transfusion Medicine, Academy of Medical Science of Ukraine, Gen. Chuprynkea Str.
🇺🇦Lviv, Ukraine