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

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:

  • Immunocompetent with severe Haemophilia A without inhibitor to FVIII, at least 12 years of age, currently receiving FVIII concentrates and have more than 150 exposures. Subjects who require elective surgergy within 6 months of starting on OPTIVATE® are permitted to be included in this study providing that the surgery could be performed using OPTIVATE® as FVIII cover.

Exclusion Criteria:

-

Sites / Locations

  • Klinika Haematologii, Akademia Medyczna w Bialymstokiu, ul.
  • Klinika Haematologii, Akademia Medyczna w Gdansku, u.
  • Klinika Haematologii, Akademia Medyczna w Lodzi, ul.
  • Klinika Haematologii, Akademia Medyczna w Lublinie, ul.
  • Klinika Haematologii, Akademia Medyczna w Poznaniu, ul.
  • Klinika Haematologii, Akademia Medyczna w Wroclawiu, ul.
  • Haemophilia Centre, Addenbrooke's Hospital, Hills Road
  • Haemophilia Centre, University Department of Haemophilia Manchester Royal Infirmary
  • Haemophilia Centre, University Hospital, Queen's 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

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
NCT02246868
Brief Title
An Open Study to Investigate the Safety and Efficacy of Optivate® in Severe Haemophilia A Patients.
Official Title
An Open Study to Investigate the Safety and Efficacy of Optivate® in Severe Haemophilia A Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
August 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 objectives of this study are to compare the first and second recovery assessments and recovery when a subject changed batch and to assess whether haemostasis was achieved with Optivate® when treating a bleed. The secondary objectives are to evaluate the clinical tolerance and safety of Optivate®.

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
Time Frame
Comparison of Baseline with 3 months post-baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Immunocompetent with severe Haemophilia A without inhibitor to FVIII, at least 12 years of age, currently receiving FVIII concentrates and have more than 150 exposures. Subjects who require elective surgergy within 6 months of starting on OPTIVATE® are permitted to be included in this study providing that the surgery could be performed using OPTIVATE® as FVIII cover. Exclusion Criteria: -
Facility Information:
Facility Name
Klinika Haematologii, Akademia Medyczna w Bialymstokiu, ul.
City
Bialystok
Country
Poland
Facility Name
Klinika Haematologii, Akademia Medyczna w Gdansku, u.
City
Gdansk
Country
Poland
Facility Name
Klinika Haematologii, Akademia Medyczna w Lodzi, ul.
City
Lodz
Country
Poland
Facility Name
Klinika Haematologii, Akademia Medyczna w Lublinie, ul.
City
Lublin
Country
Poland
Facility Name
Klinika Haematologii, Akademia Medyczna w Poznaniu, ul.
City
Poznan
Country
Poland
Facility Name
Klinika Haematologii, Akademia Medyczna w Wroclawiu, ul.
City
Wroclaw
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 Department of Haemophilia Manchester Royal Infirmary
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
Haemophilia Centre, University Hospital, Queen's Medical Centre, Clifton Boulevard
City
Nottingham
ZIP/Postal Code
NG7 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

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

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