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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	27 July 2020
Main ID:	EUCTR2006-000663-28-GB
Date of registration:	22/02/2008
Prospective Registration:	No
Primary sponsor:	Bio Products Laboratory
Public title:	An open multi-centre study in patients with von Willebrand Disease to investigate the pharmacokinetics, efficacy and safety of Optivate, a high purity, dual inactivated Factor VIII and Von Willebrand Factor concentrate - A PK study on Optivate in patients with von Willebrands Disease
Scientific title:	An open multi-centre study in patients with von Willebrand Disease to investigate the pharmacokinetics, efficacy and safety of Optivate, a high purity, dual inactivated Factor VIII and Von Willebrand Factor concentrate - A PK study on Optivate in patients with von Willebrands Disease
Date of first enrolment:	28/09/2006
Target sample size:	26
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-000663-28
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: no Open: yes 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
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. Given written informed consent.2. Be aged 12 years or older.3. Have severe VWD (VWF:RCo <20%) of known type (confirmed by one previous and one current VWF:RCo result of <20%) .4. Be known or expected to require a concentrate for management.5. Must have had at least one spontaneous bleed in the last 12 months which required treatment with a FVIII and VWF concentrate.6. Have a known lack of, or poor response to, Desmopressin (DDAVP), or for whom DDAVP is contraindicated.
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) no
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 2. Actively bleeding (Note: the patient can enter the study once the bleed is controlled).3. Presence of major systemic illnesses: renal disease, liver disease, or neurological or psychiatric disease which would compromise the outcome of the study in the opinion of the investigator.4. Known or suspected hypersensitivity to investigational medicinal product (IMP) or its excipients.5. Have a recent history of alcohol or drug abuse.6. Administration of a new chemical entity within the 4 months preceding enrolment.7. 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 8VWF03, in such cases patients should have completed their End-of study visit either before or on the day of screening for this study.

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

Health Condition(s) or Problem(s) studied

von Willebrands Disease

Intervention(s)

Trade Name: Optivate
Product Name: Optivate
Pharmaceutical Form: Powder and solvent for solution for injection

Primary Outcome(s)

Main Objective: Pharmacokinetcs of Optivate

Primary end point(s): AUC (0-t), AUC9)-72h), mean residence time (MRT0(0-t) and MRT (0-72h) for VWF:RCo at the baseline visit by VWD type and overall

Secondary Objective: Efficacy and Safety of Optivate

Secondary Outcome(s)

Secondary ID(s)

8VWF01

2006-000663-28-PL

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 22/02/2008
Contact:

Results

Results available:
Date Posted:
Date Completed:
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