Status:

COMPLETED

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

Lead Sponsor:

Bio Products Laboratory

Conditions:

Haemophilia B

Eligibility:

All Genders

12+ years

Phase:

PHASE3

Brief 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...

Eligibility Criteria

Inclusion

  • 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

  • \-

Key Trial Info

Start Date :

July 1 1997

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT02263456

Start Date

July 1 1997

Last Update

October 13 2014

Active Locations (7)

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Page 1 of 2 (7 locations)

1

The Royal Free Hospital, Pond Street

Hampstead, London, United Kingdom

2

The North Hampshire Hospital, Aldermaston Road

Basingstoke, United Kingdom

3

Addenbrooke's Hospital, Hills Road

Cambridge, United Kingdom

4

University Hospital of Wales, Health Park

Cardiff, United Kingdom