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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02231944

Enrollment

Unknown

Registered

2014-09-04

Start date

1997-07-31

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Haemophilia B

Brief summary

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

Interventions

BIOLOGICALReplenine®-VF (High Purity Factor IX)

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

Design outcomes

Primary

Measure	Time frame	Description
Recovery calculated from the first infusion of Replenine®-VF compared with that calculated 12 weeks later.	Baseline and 3 months post-baseline.	Safety assessments included: * assessment of tolerance at injection site * assessment of Factor IX inhibitor development * assessment of frequency and type of adverse event * routine biochemistry and haematology at the start and end of Stage 1 and at the end of the study (Stage 2, if applicable) * screening for markers of viral infection at the start and end of each stage of the study (and if patients changed batches).

Countries

Poland, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026