NCT02263456

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1997

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2001

Completed
13 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 13, 2014

Completed
Last Updated

October 13, 2014

Status Verified

August 1, 2014

Enrollment Period

4.2 years

First QC Date

September 2, 2014

Last Update Submit

October 9, 2014

Conditions

Haemophilia B

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Current Factor IX

ACTIVE COMPARATOR
Biological: Replenine®-VF (High Purity Factor IX)

Replenine®-VF

EXPERIMENTAL
Biological: Replenine®-VF (High Purity Factor IX)

Interventions

Replenine®-VF (High Purity Factor IX)BIOLOGICAL
Current Factor IXReplenine®-VF

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

The Royal Free Hospital, Pond Street

Hampstead, London, United Kingdom

Location

The North Hampshire Hospital, Aldermaston Road

Basingstoke, United Kingdom

Location

Addenbrooke's Hospital, Hills Road

Cambridge, United Kingdom

Location

University Hospital of Wales, Health Park

Cardiff, United Kingdom

Location

Kingston General Hospital, Beverly Road

Hull, United Kingdom

Location

Leicester Royal Infirmary, Infirmary Square

Leicester, United Kingdom

Location

Lincoln County Hospital, Greetwell Road

Lincoln, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Hemophilia B

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, X-Linked

Study Design

Study Type
interventional
Phase
phase 3
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2014

First Posted

October 13, 2014

Study Start

July 1, 1997

Primary Completion

September 1, 2001

Last Updated

October 13, 2014

Record last verified: 2014-08

Locations

GB(7)