An Open-study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Subjects Undergoing 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

NCT02250573

R9VFSUR

Details and patient eligibility

About

The main objectives of this study were to investigate the safety and efficacy of Replenine®-VF administered in appropriate dosage by bolus infusion to prevent bleeding and achieve haemostasis in subjects with haemophilia B undergoing surgery.

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with moderate to severe haemophilia B undergoing major surgery requiring an in-patient stay of generally 5 to 10 days.

Exclusion criteria

Trial design

0 participants in 1 patient group

Replenine®-VF

Experimental group

Treatment:

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