An Open Study to Investigate the Safety and Efficacy of Replenine®-VF in Severe Haemophilia B Patients

February 20, 2018 updated by: Bio Products Laboratory

An Open Study to Investigate the Safety and Efficacy of Replenine®-VF in Severe Haemophilia B Patients.

To compare the first and second recovery assessments on Replenine®-VF and to evaluate recovery of different batches if patients changed batches during the study.

To evaluate Replenine®-VF in terms of long-term clinical efficacy, tolerance and safety

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
      • Lodz, Poland
        • Klinika Hematologii Instytutu Medycyny Wewnetrznej
      • Lublin, Poland
        • Klinika Hematologii AM Lublin, ul.Jaczewskiego 8
  • United Kingdom
      • Cambridge, United Kingdom
        • Addenbrooke's Hospital, Hills Road
      • Cardiff, United Kingdom
        • University Hospital of Wales, Heath Park
      • London, United Kingdom
        • The Royal London Hospital
      • Manchester, United Kingdom
        • Manchester Royal Infirmary, Oxford Road
      • Norwich, United Kingdom
        • Norwich and Norfolk Hospital

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

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Previously treated patients
  • At least 12 years of age
  • Severe Haemophilia B and without inhibitor to factor IX

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
Recovery calculated from the first infusion of Replenine®-VF compared with that calculated 12 weeks later.
Time Frame: Baseline and 3 months post-baseline.

Safety assessments included:

  • assessment of tolerance at injection site
  • assessment of Factor IX inhibitor development
  • assessment of frequency and type of adverse event
  • routine biochemistry and haematology at the start and end of Stage 1 and at the end of the study (Stage 2, if applicable)
  • screening for markers of viral infection at the start and end of each stage of the study (and if patients changed batches).
Baseline and 3 months post-baseline.

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

July 1, 1997

Primary Completion (Actual)

October 1, 2003

Study Registration Dates

First Submitted

September 2, 2014

First Submitted That Met QC Criteria

September 3, 2014

First Posted (Estimate)

September 4, 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

  • R9VFSE

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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