A Study to Compare the Pharmacokinetics and Safety of Current Factor VIII Concentrate and Optivate® in Haemophilia A.

February 14, 2018 updated by: Bio Products Laboratory

An Open Study to Compare the Pharmacokinetics and Safety of Current Factor VIII Concentrate and Optivate® in Severe Haemophilia A Patients.

The main objective of the study is to compare the pharmacokinetics of Optivate® with the subject's current FVIII concentrate when given as a bolus dose of 50IU/kg. The secondary objective is to compare the first and second pharmacokinetic assessments on Optivate® (and recovery if a subject changes batch) to evaluate Optivate® in terms of clinical 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
      • Debinki 7, 80-211 Gdansk, Poland
        • Klinika Haematologii, Akademia Medyczna w Gdansku, ul.
      • Dr K Jaczewskiego 8, 20-090, Lublin, Poland
        • Klinika Haematologii, Akademia Medyczna w Lublinie, ul.
      • Pabianicka 62, 93-513 Lodz, Poland
        • Klinika Haematologii, Akademia Medyczna w Lodzi, ul.
  • United Kingdom
      • Clifton Boulevard, Nottingham, United Kingdom, N67 2UH
        • Haemophilia Centre, University Hospital, Queens Medical Centre
      • Glossop Road, Sheffield, United Kingdom, S10 2JF
        • Sheffield Haemophilia & Thrombosis Centre, Royal Hallamshire Hospital
      • Manchester, United Kingdom, M13 9WL
        • Haemophilia Centre, University Dept. of Haemophilia, Manchester Royal Infirmary
      • Tremona Road, Southampton, United Kingdom, SO16 6YD
        • Haemophilia Centre, Southampton General Hospital
    • Cambridgeshire
      • Hills Road, Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
        • Haemophilia Centre, Addenbrooke's 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

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Previously treated subjects with severe Haemophilia A (<2% basal FVIII activity) without inhibitor to Factor VIII, at least 12 years of age, currently receiving FVIII concentrate and with more than 20 exposure 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: Optivate®
Optivate® (Human Coagulation Factor VIII)
Biological: Optivate® (Human Coagulation Factor VIII)
Active Comparator: Current Factor VIII
Optivate® (Human Coagulation Factor VIII)
Biological: Optivate® (Human Coagulation Factor VIII)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PK parameters for FVIII:C
Time Frame: Pre-dose, 15, 30 min, 1, 3, 6, 9, 24, 28, 32, 48 hours post-dose
Pre-dose, 15, 30 min, 1, 3, 6, 9, 24, 28, 32, 48 hours 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

October 1, 2001

Primary Completion (Actual)

January 1, 2004

Study Registration Dates

First Submitted

September 2, 2014

First Submitted That Met QC Criteria

September 19, 2014

First Posted (Estimate)

September 23, 2014

Study Record Updates

Last Update Posted (Actual)

February 15, 2018

Last Update Submitted That Met QC Criteria

February 14, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8VWFPK

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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