An Open-study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Subjects Undergoing Surgery
- Conditions
- Haemophilia B
- Interventions
- Biological: Replenine®-VF (High Purity Factor IX)
- Registration Number
- NCT02250573
- Lead Sponsor
- Bio Products Laboratory
- Brief Summary
The main objectives of this study were to investigate the safety and efficacy of Replenine®-VF administered in appropriate dosage by bolus infusion to prevent bleeding and achieve haemostasis in subjects with haemophilia B undergoing surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
- Subjects with moderate to severe haemophilia B undergoing major surgery requiring an in-patient stay of generally 5 to 10 days.
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 Incremental recovery for Factor IX 90 min post-dose Incremental recovery is defined as peak rise in plasma Factor IX levels divided by Factor IX dose in IU/KG
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Samodzielny Publiczny Zaklad Opieki Zdrowotnej nad Matka I Dzieckiem, ul. Krysiewicza 7/8.
🇵🇱Poznan, Poland
Spitalul de urgenta pentru copii "Louis Turcana", Str. losef Nemoianu 2.
🇷🇴Timisoara, Romania
Institutul National de Haemtologie, 2-8 Constantin Caracas Str.
🇷🇴Bucharest, Romania
Haematology Centre, Russian Academy if Medical Sciences, 4a Novozykovsky Proezed.
🇷🇺Moscow, Russian Federation
Kirov Research Institute of Haematology, 72 Krasnoarmeyskaya ul.
🇷🇺Kirov, Russian Federation