A Study to Compare the Pharmacokinetics and Safety of Replenine®-VF, Replenine® or Other Factor IX in Haemophilia B

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.

Timeline

Start

1997-07

Primary completion

2001-09

Completion

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Drugs

Indications