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

Phase 3

Completed

• Conditions: Haemophilia A
• Interventions: Biological: Optivate® (Human Coagulation Factor VIII)

• Registration Number: NCT02250482
• Lead Sponsor: Bio Products Laboratory

Brief Summary

The main objective of the study is to investigate the safety and efficacy of Optivate®, administered in appropriate dosage to present bleeding and achieve haemostasis in patients with Haemophilia A undergoing surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-11
• Primary Completion: 2003-08
• Study First Submitted: 2014-09-02
• Study First Submitted QC: 2014-09-24
• Study First Posted: 2014-09-26
• 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

• Diagnosed with Haemophilia A, at least 12 years of age, due to undergo surgery and have a lifetime exposure of at least 20 exposures to a FVIII concentrate.

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Optivate®	Optivate® (Human Coagulation Factor VIII)	Optivate® (Human Coagulation Factor VIII)

Primary Outcome Measures

Name	Time	Method
Incremental Recovery for plasma Factor VIII	90 minutes after pre-operative bolus dose	Incremental recovery is defined as peak rise in plasma Factor VIII levels divided by Factor VIII dose in IU/KG

Trial Locations

Locations (8)

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

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

Klinika Haematologii, Akademia Medyczna w Poznaniu, ul.; 🇵🇱 Szkolna 8/12, 61-833 Poznan, Poland

Haemophilia Centre, Addenbrooke's Hospital, Hills Road; 🇬🇧 Cambridge, United Kingdom

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

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

Klinika Haematologii, Akademia Medyczna w Lublinie, ul.; 🇵🇱 Dr K Jaczewskiego 8, 20-090, Lublin, Poland

Klinika Haematologii, Akademia Medyczna w Gdansku, ul.; 🇵🇱 Debinki 7, 80-211 Gdansk, Poland