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

Primary Purpose

Haemophilia B

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Replenine®-VF (High Purity Factor IX)
Sponsored by
Bio Products Laboratory
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Haemophilia B

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

-

Sites / Locations

  • Klinika Hematologii Instytutu Medycyny Wewnetrznej
  • Klinika Hematologii AM Lublin, ul.Jaczewskiego 8
  • Addenbrooke's Hospital, Hills Road
  • University Hospital of Wales, Heath Park
  • The Royal London Hospital
  • Manchester Royal Infirmary, Oxford Road
  • Norwich and Norfolk Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Replenine®-VF

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
September 2, 2014
Last Updated
February 20, 2018
Sponsor
Bio Products Laboratory
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1. Study Identification

Unique Protocol Identification Number
NCT02231944
Brief Title
An Open Study to Investigate the Safety and Efficacy of Replenine®-VF in Severe Haemophilia B Patients
Official Title
An Open Study to Investigate the Safety and Efficacy of Replenine®-VF in Severe Haemophilia B Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
July 1997 (undefined)
Primary Completion Date
October 2003 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bio Products Laboratory

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Haemophilia B

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3

8. Arms, Groups, and Interventions

Arm Title
Replenine®-VF
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Replenine®-VF (High Purity Factor IX)
Primary Outcome Measure Information:
Title
Recovery calculated from the first infusion of Replenine®-VF compared with that calculated 12 weeks later.
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Previously treated patients At least 12 years of age Severe Haemophilia B and without inhibitor to factor IX Exclusion Criteria: -
Facility Information:
Facility Name
Klinika Hematologii Instytutu Medycyny Wewnetrznej
City
Lodz
Country
Poland
Facility Name
Klinika Hematologii AM Lublin, ul.Jaczewskiego 8
City
Lublin
Country
Poland
Facility Name
Addenbrooke's Hospital, Hills Road
City
Cambridge
Country
United Kingdom
Facility Name
University Hospital of Wales, Heath Park
City
Cardiff
Country
United Kingdom
Facility Name
The Royal London Hospital
City
London
Country
United Kingdom
Facility Name
Manchester Royal Infirmary, Oxford Road
City
Manchester
Country
United Kingdom
Facility Name
Norwich and Norfolk Hospital
City
Norwich
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.bpl.co.uk
Description
Related Info

Learn more about this trial

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

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