An Open Study to Investigate the Safety and Efficacy of Replenine®-VF in Severe Haemophilia B Patients

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

NCT02231944

R9VFSE

Details and patient eligibility

About

To compare the first and second recovery assessments on Replenine®-VF and to evaluate recovery of different batches if patients changed batches during the study.

To evaluate Replenine®-VF in terms of long-term clinical efficacy, tolerance and safety

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Previously treated patients
• At least 12 years of age
• Severe Haemophilia B and without inhibitor to factor IX

Exclusion criteria

Trial design

0 participants in 1 patient group

Replenine®-VF

Experimental group

Treatment:

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