Trial | NCT02263456  Report issue

Title

A Study to Compare the Pharmacokinetics and Safety of Replenine®-VF, Replenine® or Other Factor IX in Haemophilia B
An Open Study to Compare the Pharmacokinetics and Safety of Replenine®-VF and Replenine® or Any Other High Purity Factor IX Concentrate, in Severe Haemophilia B Patients.

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    None
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 Started
Jul 31
1997
Primary Completion
Sep 30
2001
Last Update
Oct 13
2014
Estimate

Biological Replenine®-VF (High Purity Factor IX)

Current Factor IX Active Comparator

Replenine®-VF Experimental

Criteria 

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:

-
No Results Posted