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A Study to Compare the Pharmacokinetics and Safety of Replenine®-VF, Replenine® or Other Factor IX in Haemophilia B

Primary Purpose

Haemophilia B

Status
Completed
Phase
Phase 3
Locations
United Kingdom
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:

  • Patients aged 12 years or over
  • At least 20 exposures suffering from severe Haemophilia B and without inhibitors to Factor IX and on Replenine® or any other high purity Factor IX product

Exclusion Criteria:

-

Sites / Locations

  • The Royal Free Hospital, Pond Street
  • The North Hampshire Hospital, Aldermaston Road
  • Addenbrooke's Hospital, Hills Road
  • University Hospital of Wales, Health Park
  • Kingston General Hospital, Beverly Road
  • Leicester Royal Infirmary, Infirmary Square
  • Lincoln County Hospital, Greetwell Road

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Current Factor IX

Replenine®-VF

Arm Description

Outcomes

Primary Outcome Measures

Area under the concentration/time curve (AUC) for plasma Factor IX

Secondary Outcome Measures

Full Information

First Posted
September 2, 2014
Last Updated
October 9, 2014
Sponsor
Bio Products Laboratory
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1. Study Identification

Unique Protocol Identification Number
NCT02263456
Brief Title
A Study to Compare the Pharmacokinetics and Safety of Replenine®-VF, Replenine® or Other Factor IX in Haemophilia B
Official Title
An Open Study to Compare the Pharmacokinetics and Safety of Replenine®-VF and Replenine® or Any Other High Purity Factor IX Concentrate, in Severe Haemophilia B Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
July 1997 (undefined)
Primary Completion Date
September 2001 (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
The purpose of this study is: to compare the pharmacokinetics of Replenine®-VF and Replenine® or any other high purity Factor IX concentrate, when given as a bolus dose of 75IU/kg. to compare the 1st and 2nd pharmacokinetic assessments on Replenine®-VF (conducted 3 months apart) and recovery if patients changes batches. to evaluate Replenine®-VF in terms of clinical tolerance and safety in patients with severe haemophilia B.

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
Current Factor IX
Arm Type
Active Comparator
Arm Title
Replenine®-VF
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Replenine®-VF (High Purity Factor IX)
Primary Outcome Measure Information:
Title
Area under the concentration/time curve (AUC) for plasma Factor IX
Time Frame
Pre-dose, 10, 30 min, 1, 3, 6, 9, 12, 24, 30, 36, 50, 56 hr post-dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged 12 years or over At least 20 exposures suffering from severe Haemophilia B and without inhibitors to Factor IX and on Replenine® or any other high purity Factor IX product Exclusion Criteria: -
Facility Information:
Facility Name
The Royal Free Hospital, Pond Street
City
Hampstead
State/Province
London
Country
United Kingdom
Facility Name
The North Hampshire Hospital, Aldermaston Road
City
Basingstoke
Country
United Kingdom
Facility Name
Addenbrooke's Hospital, Hills Road
City
Cambridge
Country
United Kingdom
Facility Name
University Hospital of Wales, Health Park
City
Cardiff
Country
United Kingdom
Facility Name
Kingston General Hospital, Beverly Road
City
Hull
Country
United Kingdom
Facility Name
Leicester Royal Infirmary, Infirmary Square
City
Leicester
Country
United Kingdom
Facility Name
Lincoln County Hospital, Greetwell Road
City
Lincoln
Country
United Kingdom

12. IPD Sharing Statement

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

Learn more about this trial

A Study to Compare the Pharmacokinetics and Safety of Replenine®-VF, Replenine® or Other Factor IX in Haemophilia B

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