MedTrace Logo

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

NCT02263456 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2014-10-13

No results posted yet for this study

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.

Conditions

  • Haemophilia B

Interventions

BIOLOGICAL

Replenine®-VF (High Purity Factor IX)

Sponsors & Collaborators

  • Bio Products Laboratory

    lead OTHER

Study Design

Purpose
TREATMENT

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-07-31
Primary Completion
2001-09-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02263456 on ClinicalTrials.gov