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

NCT ID: NCT02250482

Last Updated: 2018-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2001-11-30

Brief Summary

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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

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Conditions

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Haemophilia A

Study Design

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Primary Study Purpose

TREATMENT

Study Groups

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Optivate®

Optivate® (Human Coagulation Factor VIII)

Group Type EXPERIMENTAL

Optivate® (Human Coagulation Factor VIII)

Intervention Type BIOLOGICAL

Interventions

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Optivate® (Human Coagulation Factor VIII)

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

\-
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bio Products Laboratory

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Klinika Haematologii, Akademia Medyczna w Gdansku, ul.

Debinki 7, 80-211 Gdansk, , Poland

Site Status

Klinika Haematologii, Akademia Medyczna w Lublinie, ul.

Dr K Jaczewskiego 8, 20-090, Lublin, , Poland

Site Status

Klinika Haematologii, Akademia Medyczna w Poznaniu, ul.

Szkolna 8/12, 61-833 Poznan, , Poland

Site Status

Haemophilia Centre, Addenbrooke's Hospital, Hills Road

Cambridge, , United Kingdom

Site Status

Haemophilia Centre, University Dept. of Haemophilia, Manchester Royal Infirmary

Manchester, , United Kingdom

Site Status

Haemophilia Centre, University Hospital, Queens Medical Centre, Clifton Boulevard

Nottingham, , United Kingdom

Site Status

Sheffield Haemophilia & Thrombosis Centre, Royal Hallamshire Hospital, Glossop Road

Sheffield, , United Kingdom

Site Status

Haemophilia Centre, Southampton General Hospital, Tremona Road

Southampton, , United Kingdom

Site Status

Countries

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Poland United Kingdom

Related Links

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Other Identifiers

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8VWF02

Identifier Type: -

Identifier Source: org_study_id

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