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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02246868
Recruitment Status : Completed
First Posted : September 23, 2014
Last Update Posted : February 15, 2018
Sponsor:
Information provided by (Responsible Party):
Bio Products Laboratory

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®.

Condition or disease Intervention/treatment Phase
Haemophilia A Biological: Optivate® (Human Coagulation Factor VIII) Phase 3

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: An Open Study to Investigate the Safety and Efficacy of Optivate® in Severe Haemophilia A Patients.
Study Start Date : September 2001
Actual Primary Completion Date : August 2004


Arm Intervention/treatment
Experimental: Optivate®
Optivate® (Human Coagulation Factor VIII)
Biological: Optivate® (Human Coagulation Factor VIII)



Primary Outcome Measures :
  1. Incremental Recovery [ Time Frame: Comparison of Baseline with 3 months post-baseline ]


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02246868


Locations
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Poland
Klinika Haematologii, Akademia Medyczna w Bialymstokiu, ul.
Bialystok, Poland
Klinika Haematologii, Akademia Medyczna w Gdansku, u.
Gdansk, Poland
Klinika Haematologii, Akademia Medyczna w Lodzi, ul.
Lodz, Poland
Klinika Haematologii, Akademia Medyczna w Lublinie, ul.
Lublin, Poland
Klinika Haematologii, Akademia Medyczna w Poznaniu, ul.
Poznan, Poland
Klinika Haematologii, Akademia Medyczna w Wroclawiu, ul.
Wroclaw, Poland
United Kingdom
Haemophilia Centre, Addenbrooke's Hospital, Hills Road
Cambridge, United Kingdom, CB2 2QQ
Haemophilia Centre, University Department of Haemophilia Manchester Royal Infirmary
Manchester, United Kingdom, M13 9WL
Haemophilia Centre, University Hospital, Queen's Medical Centre, Clifton Boulevard
Nottingham, United Kingdom, NG7 2UH
Sheffield Haemophilia & Thrombosis Centre, Royal Hallamshire Hospital, Glossop Road
Sheffield, United Kingdom, S10 2JF
Haemophilia Centre, Southampton General Hospital, Tremona Road
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Bio Products Laboratory

Additional Information:
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Responsible Party: Bio Products Laboratory
ClinicalTrials.gov Identifier: NCT02246868     History of Changes
Other Study ID Numbers: 8VWFSE
First Posted: September 23, 2014    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
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Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Factor VIII
Coagulants