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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02250573

Enrollment

Unknown

Registered

2014-09-26

Start date

2005-12-31

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

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.

Interventions

BIOLOGICALReplenine®-VF (High Purity Factor IX)

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame	Description
Incremental recovery for Factor IX	90 min post-dose	Incremental recovery is defined as peak rise in plasma Factor IX levels divided by Factor IX dose in IU/KG

Countries

Poland, Romania, Russia

Outcome results

None listed

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