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

Phase 3

Completed

• Conditions: Von Willebrand Disease

• Registration Number: NCT02246881
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-10
• Primary Completion: 2004-01
• Study First Submitted: 2014-09-02
• Study First Submitted QC: 2014-09-19
• Study First Posted: 2014-09-23
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-14
• Last Update Posted: 2018-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PK parameters for FVIII:C	Pre-dose, 15, 30 min, 1, 3, 6, 9, 24, 28, 32, 48 hours post-dose

Trial Locations

Locations (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, United Kingdom

Haemophilia Centre, University Hospital, Queens Medical Centre; 🇬🇧 Clifton Boulevard, Nottingham, United Kingdom

Sheffield Haemophilia & Thrombosis Centre, Royal Hallamshire Hospital; 🇬🇧 Glossop Road, Sheffield, United Kingdom

Haemophilia Centre, University Dept. of Haemophilia, Manchester Royal Infirmary; 🇬🇧 Manchester, United Kingdom

Haemophilia Centre, Southampton General Hospital; 🇬🇧 Tremona Road, Southampton, United Kingdom