A Study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Patients Under the Age of 6 Years

October 9, 2014 updated by: Bio Products Laboratory

An Open Multi-centre Phase III Study to Investigate the Safety and Efficacy of Replenine®-VF in Severe Haemophilia B Patients Under the Age of 6 Years

The objective of this study was to assess the safety and efficacy of Replenine®-VF in children enrolled in the study, under the age of six years, with severe haemophilia B.

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
      • Warsaw, Poland
        • Samodzielny Publiczny Dzieciecy Szpital Kliniczny, Oddzial Pediatrii, Hematologii I Onkologii, ul. Marszalkowska 24, 00-576
  • Ukraine
      • Donetsk, Ukraine, 83045
        • Institute of Urgent and Recovery Surgery, Academy of Medical Science of Ukraine, Leninski Avenue
      • Kiev, Ukraine
        • Institute of Haematology and Transfusiology, Academy of Medical Science of Ukrainem Berlynskogo Str.
      • Lviv, Ukraine, 79044
        • Institute of Blood Pathology and Transfusion Medicine, Academy of Medical Science of Ukraine, Gen. Chuprynkea Str.

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

No older than 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients under six years of age at the time of entry with severe Haemophilia B at the time of diagnosis without inhibitors to FIX and requiring Factor IX therapy.

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?

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
Time Frame
Amount of Factor IX Administered per Month (IU/KG)
Time Frame: 26 Weeks
26 Weeks

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

August 1, 2005

Primary Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

September 2, 2014

First Submitted That Met QC Criteria

October 9, 2014

First Posted (Estimate)

October 13, 2014

Study Record Updates

Last Update Posted (Estimate)

October 13, 2014

Last Update Submitted That Met QC Criteria

October 9, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R9VF03

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.

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