NCT02250573

Brief Summary

The main objectives of this study were to investigate the safety and efficacy of Replenine®-VF administered in appropriate dosage by bolus infusion to prevent bleeding and achieve haemostasis in subjects with haemophilia B undergoing surgery.

Trial Health

85
On Track

Trial Health Score

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

Geographic Reach
3 countries

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

December 1, 2005

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
8.4 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

February 1, 2018

Enrollment Period

4 months

First QC Date

September 2, 2014

Last Update Submit

February 20, 2018

Conditions

Haemophilia B

Outcome Measures

Primary Outcomes (1)

  • Incremental recovery for Factor IX

    Incremental recovery is defined as peak rise in plasma Factor IX levels divided by Factor IX dose in IU/KG

    90 min post-dose

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

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

You may qualify if:

  • Subjects with moderate to severe haemophilia B undergoing major surgery requiring an in-patient stay of generally 5 to 10 days.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Samodzielny Publiczny Zaklad Opieki Zdrowotnej nad Matka I Dzieckiem, ul. Krysiewicza 7/8.

Poznan, 61-825, Poland

Location

Institutul National de Haemtologie, 2-8 Constantin Caracas Str.

Bucharest, Romania

Location

Spitalul de urgenta pentru copii "Louis Turcana", Str. losef Nemoianu 2.

Timișoara, Romania

Location

Kirov Research Institute of Haematology, 72 Krasnoarmeyskaya ul.

Kirov, 610027, Russia

Location

Haematology Centre, Russian Academy if Medical Sciences, 4a Novozykovsky Proezed.

Moscow, 125167, Russia

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

September 26, 2014

Study Start

December 1, 2005

Primary Completion

April 1, 2006

Last Updated

February 22, 2018

Record last verified: 2018-02

Locations

PL(1)RO(2)RU(2)