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Clinical Trial Summary

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.


Clinical Trial Description

n/a


Study Design

Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02263456
Study type Interventional
Source Bio Products Laboratory
Contact
Status Completed
Phase Phase 3
Start date July 1997

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