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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

1997-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Haemophilia B

Study Design

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Primary Study Purpose

TREATMENT

Study Groups

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Current Factor IX

Group Type ACTIVE_COMPARATOR

Replenine®-VF (High Purity Factor IX)

Intervention Type BIOLOGICAL

Replenine®-VF

Group Type EXPERIMENTAL

Replenine®-VF (High Purity Factor IX)

Intervention Type BIOLOGICAL

Interventions

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Replenine®-VF (High Purity Factor IX)

Intervention Type BIOLOGICAL

Eligibility Criteria

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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