A Study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Patients Under the Age of 6 Years

Bio Products Laboratory

Overview

The objective of this study was to assess the safety and efficacy of Replenine®-VF in children enrolled in the study, under the age of six years, with severe haemophilia B.

Study Type

INTERVENTIONAL

Conditions

Haemophilia B

Interventions

Replenine®-VF (High Purity Factor IX)BIOLOGICAL

Eligibility

Sex: ALLMax age: 6 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients under six years of age at the time of entry with severe Haemophilia B at the time of diagnosis without inhibitors to FIX and requiring Factor IX therapy. Exclusion Criteria: \-

Locations (4)

Samodzielny Publiczny Dzieciecy Szpital Kliniczny, Oddzial Pediatrii, Hematologii I Onkologii, ul. Marszalkowska 24, 00-576

Warsaw, Poland

Institute of Urgent and Recovery Surgery, Academy of Medical Science of Ukraine, Leninski Avenue

Donetsk, Ukraine

Institute of Haematology and Transfusiology, Academy of Medical Science of Ukrainem Berlynskogo Str.

Kiev, Ukraine

Institute of Blood Pathology and Transfusion Medicine, Academy of Medical Science of Ukraine, Gen. Chuprynkea Str.

Outcomes

Primary Outcomes

Amount of Factor IX Administered per Month (IU/KG)

Time frame: 26 Weeks

Data from ClinicalTrials.gov

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