A Study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Patients Undergoing Major Surgery.

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

NCT02250560

R9VFCIMS

Details and patient eligibility

About

The main objective of the study is to investigate the safety and efficacy of Replenine®-VF administered by continuous infusion in appropriate dosage to prevent bleeding and achieve haemostasis in patients with haemophilia B undergoing major surgery.

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with moderate to severe Haemophilia B (≤5% baseline Factor IX level) due to undergo major surgery, previously treated patients, at least 16 years of age without inhibitors, currently receiving Factor IX concentrate.

Exclusion criteria

Trial design

0 participants in 1 patient group

Replenine®-VF

Experimental group

Treatment:

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