A Study to Compare the Pharmacokinetics and Safety of Replenine®-VF, Replenine® or Other Factor IX in Haemophilia B
An Open Study to Compare the Pharmacokinetics and Safety of Replenine®-VF and Replenine® or Any Other High Purity Factor IX Concentrate, in Severe Haemophilia B Patients.
The purpose of this study is: - to compare the pharmacokinetics of Replenine®-VF and Replenine® or any other high purity Factor IX concentrate, when given as a bolus dose of 75IU/kg. - to compare the 1st and 2nd pharmacokinetic assessments on Replenine®-VF (conducted 3 months apart) and recovery if patients changes batches. - to evaluate Replenine®-VF in terms of clinical tolerance and safety in patients with severe haemophilia B.
Area under the concentration/time curve (AUC) for plasma Factor IX
Replenine®-VF (High Purity Factor IX)
Study Arms / Comparison Groups
Current Factor IX
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Primary Completion Date
Inclusion Criteria: - Patients aged 12 years or over - At least 20 exposures suffering from severe Haemophilia B and without inhibitors to Factor IX and on Replenine® or any other high purity Factor IX product Exclusion Criteria: -
12 Years - N/A
Accepts Healthy Volunteers
Bio Products Laboratory