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

Information source: Bio Products Laboratory
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Haemophilia B

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

Phase: Phase 3

Status: Completed

Sponsored by: Bio Products Laboratory

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.

Clinical Details

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

Study design: Primary Purpose: Treatment

Primary outcome: Incremental recovery for Factor IX

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

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 and Contacts

Samodzielny Publiczny Zaklad Opieki Zdrowotnej nad Matka I Dzieckiem, ul. Krysiewicza 7/8., Poznan 61-825, Poland

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

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

Kirov Research Institute of Haematology, 72 Krasnoarmeyskaya ul., Kirov 610027, Russian Federation

Haematology Centre, Russian Academy if Medical Sciences, 4a Novozykovsky Proezed., Moscow 125167, Russian Federation

Additional Information

Starting date: December 2005
Last updated: September 24, 2014

Page last updated: August 20, 2015

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