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

Phase 3

Completed

• Conditions: Haemophilia B
• Interventions: Biological: Replenine®-VF (High Purity Factor IX)

• Registration Number: NCT02231944
• Lead Sponsor: Bio Products Laboratory

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 1997-07
• Primary Completion: 2003-10
• Study First Submitted: 2014-09-02
• Study First Submitted QC: 2014-09-03
• Study First Posted: 2014-09-04
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-20
• Last Update Posted: 2018-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Previously treated patients
• At least 12 years of age
• Severe Haemophilia B and without inhibitor to factor IX

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Replenine®-VF	Replenine®-VF (High Purity Factor IX)	-

Primary Outcome Measures

Name	Time	Method
Recovery calculated from the first infusion of Replenine®-VF compared with that calculated 12 weeks later.	Baseline and 3 months post-baseline.	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).

Trial Locations

Locations (7)

Manchester Royal Infirmary, Oxford Road; 🇬🇧 Manchester, United Kingdom

Klinika Hematologii Instytutu Medycyny Wewnetrznej; 🇵🇱 Lodz, Poland

University Hospital of Wales, Heath Park; 🇬🇧 Cardiff, United Kingdom

Addenbrooke's Hospital, Hills Road; 🇬🇧 Cambridge, United Kingdom

Norwich and Norfolk Hospital; 🇬🇧 Norwich, United Kingdom

Klinika Hematologii AM Lublin, ul.Jaczewskiego 8; 🇵🇱 Lublin, Poland

The Royal London Hospital; 🇬🇧 London, United Kingdom