Haemophilia B Clinical Trial
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.
| NCT number | NCT02263456 |
| Other study ID # | RP9VFPK |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 3 |
| First received | September 2, 2014 |
| Last updated | October 9, 2014 |
| Start date | July 1997 |
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.
| Status | Completed |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | September 2001 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 12 Years and older |
| Eligibility |
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: |
Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | The North Hampshire Hospital, Aldermaston Road | Basingstoke | |
| United Kingdom | Addenbrooke's Hospital, Hills Road | Cambridge | |
| United Kingdom | University Hospital of Wales, Health Park | Cardiff | |
| United Kingdom | The Royal Free Hospital, Pond Street | Hampstead | London |
| United Kingdom | Kingston General Hospital, Beverly Road | Hull | |
| United Kingdom | Leicester Royal Infirmary, Infirmary Square | Leicester | |
| United Kingdom | Lincoln County Hospital, Greetwell Road | Lincoln |
| Lead Sponsor | Collaborator |
|---|---|
| Bio Products Laboratory |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Area under the concentration/time curve (AUC) for plasma Factor IX | Pre-dose, 10, 30 min, 1, 3, 6, 9, 12, 24, 30, 36, 50, 56 hr post-dose |
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