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.
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Area under the concentration/time curve (AUC) for plasma Factor IX
Condition
Haemophilia B
Intervention
Replenine®-VF (High Purity Factor IX)
Study Arms / Comparison Groups
Current Factor IX
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Start Date
July 1997
Primary Completion Date
September 2001
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: -
Gender
All
Ages
12 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, ,
Location Countries
United Kingdom
Location Countries
United Kingdom
Administrative Informations
NCT ID
NCT02263456
Organization ID
RP9VFPK
Responsible Party
Sponsor
Study Sponsor
Bio Products Laboratory
Study Sponsor
, ,
Verification Date
August 2014