An Open Study to Investigate the Safety and Efficacy of Replenine®-VF in Severe Haemophilia B Patients

Phase 3CompletedNCT02231944

Bio Products Laboratory

Overview

To compare the first and second recovery assessments on Replenine®-VF and to evaluate recovery of different batches if patients changed batches during the study. To evaluate Replenine®-VF in terms of long-term clinical efficacy, tolerance and safety

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Haemophilia B

Interventions

Replenine®-VF (High Purity Factor IX)BIOLOGICAL

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Previously treated patients * At least 12 years of age * Severe Haemophilia B and without inhibitor to factor IX Exclusion Criteria: \-

Locations (7)

Klinika Hematologii Instytutu Medycyny Wewnetrznej

Lodz, Poland

Klinika Hematologii AM Lublin, ul.Jaczewskiego 8

Lublin, Poland

Addenbrooke's Hospital, Hills Road

Cambridge, United Kingdom

University Hospital of Wales, Heath Park

Cardiff, United Kingdom

Outcomes

Primary Outcomes

Recovery calculated from the first infusion of Replenine®-VF compared with that calculated 12 weeks later.

Safety assessments included: * assessment of tolerance at injection site * assessment of Factor IX inhibitor development * assessment of frequency and type of adverse event * routine biochemistry and haematology at the start and end of Stage 1 and at the end of the study (Stage 2, if applicable) * screening for markers of viral infection at the start and end of each stage of the study (and if patients changed batches).

Time frame: Baseline and 3 months post-baseline.

Data from ClinicalTrials.gov

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