A Study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Patients Under the Age of 6 Years

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

NCT02263469

R9VF03

Details and patient eligibility

About

The objective of this study was to assess the safety and efficacy of Replenine®-VF in children enrolled in the study, under the age of six years, with severe haemophilia B.

Sex: All

Ages: Under 6 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients under six years of age at the time of entry with severe Haemophilia B at the time of diagnosis without inhibitors to FIX and requiring Factor IX therapy.

Exclusion criteria

Trial design

0 participants in 1 patient group

Replenine®-VF

Experimental group

Treatment:

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