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

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.

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Key information

Conditions

Haemophilia B Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia B Hemorrhagic Disorders

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Replenine®-VF (High Purity Factor IX)

Biological

Primary outcomes

Incremental recovery for Factor IX

Time frame: 90 min post-dose

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

Sponsors and collaborators

Lead sponsor

Bio Products Laboratory

Other

Registry information

Official study title

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

Important dates

Study start: 2005
Primary completion: 2006
First posted: Sep 26, 2014
Registry last updated: Feb 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed