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An Open Study to Investigate the Safety and Efficacy of Optivate® in Haemophilia A Patients Undergoing Surgery.

Primary Purpose

Haemophilia A

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 Haemophilia A

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed with Haemophilia A, at least 12 years of age, due to undergo surgery and have a lifetime exposure of at least 20 exposures to a FVIII concentrate.

Exclusion Criteria:

-

Sites / Locations

  • Klinika Haematologii, Akademia Medyczna w Gdansku, ul.
  • Klinika Haematologii, Akademia Medyczna w Lublinie, ul.
  • Klinika Haematologii, Akademia Medyczna w Poznaniu, ul.
  • Haemophilia Centre, Addenbrooke's Hospital, Hills Road
  • Haemophilia Centre, University Dept. of Haemophilia, Manchester Royal Infirmary
  • Haemophilia Centre, University Hospital, Queens Medical Centre, Clifton Boulevard
  • Sheffield Haemophilia & Thrombosis Centre, Royal Hallamshire Hospital, Glossop Road
  • Haemophilia Centre, Southampton General Hospital, Tremona Road

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Optivate®

Arm Description

Optivate® (Human Coagulation Factor VIII)

Outcomes

Primary Outcome Measures

Incremental Recovery for plasma Factor VIII
Incremental recovery is defined as peak rise in plasma Factor VIII levels divided by Factor VIII dose in IU/KG

Secondary Outcome Measures

Full Information

First Posted
September 2, 2014
Last Updated
February 14, 2018
Sponsor
Bio Products Laboratory
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1. Study Identification

Unique Protocol Identification Number
NCT02250482
Brief Title
An Open Study to Investigate the Safety and Efficacy of Optivate® in Haemophilia A Patients Undergoing Surgery.
Official Title
An Open Study to Investigate the Safety and Efficacy of Optivate® in Haemophilia A Patients Undergoing Surgery.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
November 2001 (undefined)
Primary Completion Date
August 2003 (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 investigate the safety and efficacy of Optivate®, administered in appropriate dosage to present bleeding and achieve haemostasis in patients with Haemophilia A undergoing surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Haemophilia A

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3

8. Arms, Groups, and Interventions

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
Incremental Recovery for plasma Factor VIII
Description
Incremental recovery is defined as peak rise in plasma Factor VIII levels divided by Factor VIII dose in IU/KG
Time Frame
90 minutes after pre-operative bolus dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with Haemophilia A, at least 12 years of age, due to undergo surgery and have a lifetime exposure of at least 20 exposures to a FVIII concentrate. 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 Poznaniu, ul.
City
Szkolna 8/12, 61-833 Poznan
Country
Poland
Facility Name
Haemophilia Centre, Addenbrooke's Hospital, Hills Road
City
Cambridge
ZIP/Postal Code
CB2 2QQ
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, University Hospital, Queens Medical Centre, Clifton Boulevard
City
Nottingham
ZIP/Postal Code
N67 2UH
Country
United Kingdom
Facility Name
Sheffield Haemophilia & Thrombosis Centre, Royal Hallamshire Hospital, Glossop Road
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
Facility Name
Haemophilia Centre, Southampton General Hospital, Tremona Road
City
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

An Open Study to Investigate the Safety and Efficacy of Optivate® in Haemophilia A Patients Undergoing Surgery.

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