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

Bio Products Laboratory

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Haemophilia B

Interventions

Replenine®-VF (High Purity Factor IX)BIOLOGICAL

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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: \-

Locations (5)

Samodzielny Publiczny Zaklad Opieki Zdrowotnej nad Matka I Dzieckiem, ul. Krysiewicza 7/8.

Poznan, Poland

Institutul National de Haemtologie, 2-8 Constantin Caracas Str.

Bucharest, Romania

Spitalul de urgenta pentru copii "Louis Turcana", Str. losef Nemoianu 2.

Timișoara, Romania

Kirov Research Institute of Haematology, 72 Krasnoarmeyskaya ul.

Kirov, Russia

Outcomes

Primary Outcomes

Incremental recovery for Factor IX

Incremental recovery is defined as peak rise in plasma Factor IX levels divided by Factor IX dose in IU/KG

Time frame: 90 min post-dose

Data from ClinicalTrials.gov

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