search
Back to results

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

Primary Purpose

Von Willebrand Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Optivate® (Human Coagulation Factor VIII)
Sponsored by
Bio Products Laboratory
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Von Willebrand Disease

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All Sexes

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:

-

Sites / Locations

  • Klinika Haematologii, Akademia Medyczna w Gdansku, ul.
  • Klinika Haematologii, Akademia Medyczna w Lublinie, ul.
  • Klinika Haematologii, Akademia Medyczna w Lodzi, ul.
  • Haemophilia Centre, Addenbrooke's Hospital
  • Haemophilia Centre, University Hospital, Queens Medical Centre
  • Sheffield Haemophilia & Thrombosis Centre, Royal Hallamshire Hospital
  • Haemophilia Centre, University Dept. of Haemophilia, Manchester Royal Infirmary
  • Haemophilia Centre, Southampton General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Current Factor VIII

Optivate®

Arm Description

Optivate® (Human Coagulation Factor VIII)

Optivate® (Human Coagulation Factor VIII)

Outcomes

Primary Outcome Measures

PK parameters for FVIII:C

Secondary Outcome Measures

Full Information

First Posted
September 2, 2014
Last Updated
February 14, 2018
Sponsor
Bio Products Laboratory
search

1. Study Identification

Unique Protocol Identification Number
NCT02246881
Brief Title
A Study to Compare the Pharmacokinetics and Safety of Current Factor VIII Concentrate and Optivate® in Haemophilia A.
Official Title
An Open Study to Compare the Pharmacokinetics and Safety of Current Factor VIII Concentrate and Optivate® in Severe Haemophilia A Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
January 2004 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bio Products Laboratory

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Von Willebrand Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3

8. Arms, Groups, and Interventions

Arm Title
Current Factor VIII
Arm Type
Active Comparator
Arm Description
Optivate® (Human Coagulation Factor VIII)
Arm Title
Optivate®
Arm Type
Experimental
Arm Description
Optivate® (Human Coagulation Factor VIII)
Intervention Type
Biological
Intervention Name(s)
Optivate® (Human Coagulation Factor VIII)
Primary Outcome Measure Information:
Title
PK parameters for FVIII:C
Time Frame
Pre-dose, 15, 30 min, 1, 3, 6, 9, 24, 28, 32, 48 hours post-dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Eligibility Criteria
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: -
Facility Information:
Facility Name
Klinika Haematologii, Akademia Medyczna w Gdansku, ul.
City
Debinki 7, 80-211 Gdansk
Country
Poland
Facility Name
Klinika Haematologii, Akademia Medyczna w Lublinie, ul.
City
Dr K Jaczewskiego 8, 20-090, Lublin
Country
Poland
Facility Name
Klinika Haematologii, Akademia Medyczna w Lodzi, ul.
City
Pabianicka 62, 93-513 Lodz
Country
Poland
Facility Name
Haemophilia Centre, Addenbrooke's Hospital
City
Hills Road, Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
Haemophilia Centre, University Hospital, Queens Medical Centre
City
Clifton Boulevard, Nottingham
ZIP/Postal Code
N67 2UH
Country
United Kingdom
Facility Name
Sheffield Haemophilia & Thrombosis Centre, Royal Hallamshire Hospital
City
Glossop Road, Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
Facility Name
Haemophilia Centre, University Dept. of Haemophilia, Manchester Royal Infirmary
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
Haemophilia Centre, Southampton General Hospital
City
Tremona Road, Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.bpl.co.uk
Description
Related Info

Learn more about this trial

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

We'll reach out to this number within 24 hrs