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

Phase 3

Completed

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

• Registration Number: NCT02246868
• Lead Sponsor: Bio Products Laboratory

Brief Summary

The main objectives of this study are to compare the first and second recovery assessments and recovery when a subject changed batch and to assess whether haemostasis was achieved with Optivate® when treating a bleed. The secondary objectives are to evaluate the clinical tolerance and safety of Optivate®.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-09
• Primary Completion: 2004-08
• 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

• Immunocompetent with severe Haemophilia A without inhibitor to FVIII, at least 12 years of age, currently receiving FVIII concentrates and have more than 150 exposures. Subjects who require elective surgergy within 6 months of starting on OPTIVATE® are permitted to be included in this study providing that the surgery could be performed using OPTIVATE® as FVIII cover.

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	Comparison of Baseline with 3 months post-baseline

Trial Locations

Locations (11)

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

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

Haemophilia Centre, University Hospital, Queen's Medical Centre, Clifton Boulevard; 🇬🇧 Nottingham, United Kingdom

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

Klinika Haematologii, Akademia Medyczna w Bialymstokiu, ul.; 🇵🇱 Bialystok, Poland

Klinika Haematologii, Akademia Medyczna w Gdansku, u.; 🇵🇱 Gdansk, Poland

Klinika Haematologii, Akademia Medyczna w Lodzi, ul.; 🇵🇱 Lodz, Poland

Klinika Haematologii, Akademia Medyczna w Lublinie, ul.; 🇵🇱 Lublin, Poland

Klinika Haematologii, Akademia Medyczna w Poznaniu, ul.; 🇵🇱 Poznan, Poland

Klinika Haematologii, Akademia Medyczna w Wroclawiu, ul.; 🇵🇱 Wroclaw, Poland

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