An Open-study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Subjects Undergoing Surgery
Information source: Bio Products Laboratory
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Haemophilia B
Intervention: Replenine®-VF (High Purity Factor IX) (Biological)
Phase: Phase 3
Status: Completed
Sponsored by: Bio Products Laboratory
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.
Clinical Details
Official title: An Open-study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Subjects Undergoing Surgery.
Study design: Primary Purpose: Treatment
Primary outcome: Incremental recovery for Factor IX
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subjects with moderate to severe haemophilia B undergoing major surgery requiring an
in-patient stay of generally 5 to 10 days.
Exclusion Criteria:
-
Locations and Contacts
Samodzielny Publiczny Zaklad Opieki Zdrowotnej nad Matka I Dzieckiem, ul. Krysiewicza 7/8., Poznan 61-825, Poland
Institutul National de Haemtologie, 2-8 Constantin Caracas Str., Bucharest, Romania
Spitalul de urgenta pentru copii "Louis Turcana", Str. losef Nemoianu 2., Timisoara, Romania
Kirov Research Institute of Haematology, 72 Krasnoarmeyskaya ul., Kirov 610027, Russian Federation
Haematology Centre, Russian Academy if Medical Sciences, 4a Novozykovsky Proezed., Moscow 125167, Russian Federation
Additional Information
Starting date: December 2005
Last updated: September 24, 2014
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