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

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ClinicalTrials.gov Identifier: NCT02246881
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 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.

Condition or disease Intervention/treatment Phase
Von Willebrand Disease 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 Compare the Pharmacokinetics and Safety of Current Factor VIII Concentrate and Optivate® in Severe Haemophilia A Patients.
Study Start Date : October 2001
Actual Primary Completion Date : January 2004


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



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


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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:

-


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): NCT02246881


Locations
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Poland
Klinika Haematologii, Akademia Medyczna w Gdansku, ul.
Debinki 7, 80-211 Gdansk, Poland
Klinika Haematologii, Akademia Medyczna w Lublinie, ul.
Dr K Jaczewskiego 8, 20-090, Lublin, Poland
Klinika Haematologii, Akademia Medyczna w Lodzi, ul.
Pabianicka 62, 93-513 Lodz, Poland
United Kingdom
Haemophilia Centre, Addenbrooke's Hospital
Hills Road, Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
Haemophilia Centre, University Hospital, Queens Medical Centre
Clifton Boulevard, Nottingham, United Kingdom, N67 2UH
Sheffield Haemophilia & Thrombosis Centre, Royal Hallamshire Hospital
Glossop Road, Sheffield, United Kingdom, S10 2JF
Haemophilia Centre, University Dept. of Haemophilia, Manchester Royal Infirmary
Manchester, United Kingdom, M13 9WL
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: NCT02246881     History of Changes
Other Study ID Numbers: 8VWFPK
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
Von Willebrand Diseases
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Blood Platelet Disorders
Factor VIII
Coagulants