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Register:	EUCTR
Last refreshed on:	27 July 2020
Main ID:	EUCTR2006-000664-85-GB
Date of registration:	07/12/2006
Prospective Registration:	Yes
Primary sponsor:	Bio Products Laboratory
Public title:	An Open Multi-centre Study to Investigate the Safety and Efficacy of OPTIVATE®, a High Purity, Dual Inactivated Factor VIII and von Willebrand Factor Concentrate, in Patients with von Willebrand Disease who are Undergoing Surgery - A Study with OPTIVATE® in von Willebrand Disease Patients Who are Having Surgery
Scientific title:	An Open Multi-centre Study to Investigate the Safety and Efficacy of OPTIVATE®, a High Purity, Dual Inactivated Factor VIII and von Willebrand Factor Concentrate, in Patients with von Willebrand Disease who are Undergoing Surgery - A Study with OPTIVATE® in von Willebrand Disease Patients Who are Having Surgery
Date of first enrolment:	19/12/2006
Target sample size:	25
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-000664-85
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Other specify the comparator: none
Phase:	Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment
Poland	United Kingdom

Contacts

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Key inclusion & exclusion criteria

Inclusion criteria:
1. Have given written informed consent.2. Be aged 12 years or older.3. Have VWD of known type.4. Be due to undergo surgery, in which the investigator believes a VWF concentrate will be required.5. Have a known lack of, or poor response to DDAVP, or require a specific type of surgery in which a plasma-derived product is appropriate.6. Have a prothrombin time (PT) of not more than 3 seconds above the upper limit of the reference range. Female patients of child-bearing potential, with the exception of pregnant patients undergoing Caesarean surgery or normal delivery, must have a negative result on a human chorionic gonadotropin-based pregnancy test. If a female patient is or becomes sexually active, she must practice contraception by using a method of proven reliability for the duration of the study.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Have a history of inhibitor development to VWF or FVIII or a positive result at screening (positive screen for VWF inhibitor; positive screen and a result of > 0.5 BU for FVIII inhibitor).2. Presence of clinically significant renal disease, liver disease, thrombocytopenia or any other major systemic illnesses which would compromise the outcome of the study in the opinion of the investigator.3. Known or suspected hypersensitivity to investigational medicinal product (IMP) or its excipients.4. Have a recent history of alcohol or drug abuse.5. Administration of a new chemical entity within the 4 months preceding enrolment.6. Participation in any other clinical study in which investigational or marketed drugs were employed in the 30 days preceding enrolment into this study, with the exception of the BPL clinical study Protocol 8VWF01.

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

von Willebrand disease

Intervention(s)

Trade Name: Optivate
Product Name: Optivate
Product Code: N/A
Pharmaceutical Form: Powder and solvent for solution for injection

Primary Outcome(s)

Main Objective: To assess the efficacy of OPTIVATE® in preventing excessive blood loss during and after surgery.

Secondary Objective: To assess the safety of OPTIVATE® during and after surgery.

Primary end point(s): The primary end point is excessive blood loss, which will be will be assessed by a subjective assessment by the investigator of Optivate in the control of bleeding due to surgery throughout the whole study.

Secondary Outcome(s)

Secondary ID(s)

8VWF03

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 23/08/2007
Contact:

Results

Results available:
Date Posted:
Date Completed:
URL:

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