An Open-study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Subjects Undergoing Surgery

February 20, 2018 updated by: Bio Products Laboratory

An Open-study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Subjects Undergoing Surgery.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Poznan, Poland, 61-825
        • Samodzielny Publiczny Zaklad Opieki Zdrowotnej nad Matka I Dzieckiem, ul. Krysiewicza 7/8.
  • Romania
      • Bucharest, Romania
        • Institutul National de Haemtologie, 2-8 Constantin Caracas Str.
      • Timisoara, Romania
        • Spitalul de urgenta pentru copii "Louis Turcana", Str. losef Nemoianu 2.
  • Russian Federation
      • Kirov, Russian Federation, 610027
        • Kirov Research Institute of Haematology, 72 Krasnoarmeyskaya ul.
      • Moscow, Russian Federation, 125167
        • Haematology Centre, Russian Academy if Medical Sciences, 4a Novozykovsky Proezed.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Replenine®-VF
Biological: Replenine®-VF (High Purity Factor IX)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incremental recovery for Factor IX
Time Frame: 90 min post-dose
Incremental recovery is defined as peak rise in plasma Factor IX levels divided by Factor IX dose in IU/KG
90 min post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bio Products Laboratory

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

April 1, 2006

Study Registration Dates

First Submitted

September 2, 2014

First Submitted That Met QC Criteria

September 24, 2014

First Posted (Estimate)

September 26, 2014

Study Record Updates

Last Update Posted (Actual)

February 22, 2018

Last Update Submitted That Met QC Criteria

February 20, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R9VFSUR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Haemophilia B

Clinical Trials on Replenine®-VF (High Purity Factor IX)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Egypt

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe