A Study to Compare the Pharmacokinetics and Safety of Current Factor VIII Concentrate and Optivate® in Haemophilia A.
Information source: Bio Products Laboratory
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Von Willebrand Disease
Intervention: Optivate® (Human Coagulation Factor VIII) (Biological)
Phase: Phase 3
Status: Completed
Sponsored by: Bio Products Laboratory
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.
Clinical Details
Official title: An Open Study to Compare the Pharmacokinetics and Safety of Current Factor VIII Concentrate and Optivate® in Severe Haemophilia A Patients.
Study design: Primary Purpose: Treatment
Primary outcome: PK parameters for FVIII:C
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
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:
-
Locations and Contacts
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, 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
Haemophilia Centre, Addenbrooke's Hospital, Hills Road, Cambridge, Cambridgeshire CB2 2QQ, United Kingdom
Additional Information
Starting date: October 2001
Last updated: September 19, 2014
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