NCT02250560

Brief Summary

The main objective of the study is to investigate the safety and efficacy of Replenine®-VF administered by continuous infusion in appropriate dosage to prevent bleeding and achieve haemostasis in patients with haemophilia B undergoing major surgery.

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

5 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

April 1, 2000

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2003

Completed
10.8 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2014

Completed
24 days until next milestone

First Posted

Study publicly available on registry

September 26, 2014

Completed
Last Updated

February 22, 2018

Status Verified

August 1, 2014

Enrollment Period

3.6 years

First QC Date

September 2, 2014

Last Update Submit

February 19, 2018

Conditions

Haemophilia B

Outcome Measures

Primary Outcomes (1)

  • Assessment of control of prevention of bleeding

    Investigator's assessment as excellent, good, moderate or none.

    End of study (Day 5 to Day 10)

Study Arms (1)

Replenine®-VF

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

Interventions

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

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with moderate to severe Haemophilia B (≤5% baseline Factor IX level) due to undergo major surgery, previously treated patients, at least 16 years of age without inhibitors, currently receiving Factor IX concentrate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

North Hampshire Haemophilia Centre, Uplands House, North Hampshire Hospital, Aldermaston Road

Basingstoke, RG24 9NA, United Kingdom

Location

Haemophilia Centre, The Royal London Hospital, White Chapel

London, E1 1BB, United Kingdom

Location

Haemophilia Centre and Haemostasis Unit, Royal Free Hospital, Pond Street

London, NW3 2QG, United Kingdom

Location

Manchester Thrombosis and Haemostasis Centre, University of Manchester, Department of Haematology, Manchester Royal Infirmary, Oxford Road

Manchester, M13 9WL, United Kingdom

Location

Haemophilia Centre, Southampton General Hospital, Tremona Road

Southampton, SO16 6YD, 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2014

First Posted

September 26, 2014

Study Start

April 1, 2000

Primary Completion

November 1, 2003

Last Updated

February 22, 2018

Record last verified: 2014-08

Locations

GB(5)