A Study to Compare the Pharmacokinetics and Safety of Current Factor VIII Concentrate and Optivate® in Haemophilia A.
An Open Study to Compare the Pharmacokinetics and Safety of Current Factor VIII Concentrate and Optivate® in Severe Haemophilia A Patients.
1 other identifier
interventional
N/A
2 countries
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 2, 2014
CompletedFirst Posted
Study publicly available on registry
September 23, 2014
CompletedFebruary 15, 2018
February 1, 2018
2.3 years
September 2, 2014
February 14, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
PK parameters for FVIII:C
Pre-dose, 15, 30 min, 1, 3, 6, 9, 24, 28, 32, 48 hours post-dose
Study Arms (2)
Current Factor VIII
ACTIVE COMPARATOROptivate® (Human Coagulation Factor VIII)
Optivate®
EXPERIMENTALOptivate® (Human Coagulation Factor VIII)
Interventions
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
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
Haemophilia Centre, Addenbrooke's Hospital
Hills Road, Cambridge, Cambridgeshire, CB2 2QQ, United Kingdom
Haemophilia Centre, University Hospital, Queens Medical Centre
Clifton Boulevard, Nottingham, N67 2UH, United Kingdom
Sheffield Haemophilia & Thrombosis Centre, Royal Hallamshire Hospital
Glossop Road, Sheffield, S10 2JF, United Kingdom
Haemophilia Centre, University Dept. of Haemophilia, Manchester Royal Infirmary
Manchester, M13 9WL, United Kingdom
Haemophilia Centre, Southampton General Hospital
Tremona Road, Southampton, SO16 6YD, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Purpose
- TREATMENT
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2014
First Posted
September 23, 2014
Study Start
October 1, 2001
Primary Completion
January 1, 2004
Last Updated
February 15, 2018
Record last verified: 2018-02