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

Bio Products Laboratory

Status and phase: Completed; Phase 3

Conditions: Haemophilia B

Treatments: Biological: Replenine®-VF (High Purity Factor IX)

Study type: Interventional

Funder types: Other

Identifiers

NCT02263456

RP9VFPK

Details and patient eligibility

About

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.

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 2 patient groups

Current Factor IX

Active Comparator group

Treatment:

Biological: Replenine®-VF (High Purity Factor IX)

Replenine®-VF

Experimental group

Treatment:

Biological: Replenine®-VF (High Purity Factor IX)