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

Bio Products Laboratory

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Haemophilia B

Interventions

Replenine®-VF (High Purity Factor IX)BIOLOGICAL

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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: \-

Locations (7)

The Royal Free Hospital, Pond Street

Hampstead, London, United Kingdom

The North Hampshire Hospital, Aldermaston Road

Basingstoke, United Kingdom

Addenbrooke's Hospital, Hills Road

Cambridge, United Kingdom

University Hospital of Wales, Health Park

Cardiff, United Kingdom

Outcomes

Primary Outcomes

Area under the concentration/time curve (AUC) for plasma Factor IX

Time frame: Pre-dose, 10, 30 min, 1, 3, 6, 9, 12, 24, 30, 36, 50, 56 hr post-dose

Data from ClinicalTrials.gov

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