Optivate in People With Von Willebrand Disease Undergoing Surgery

March 2, 2010 updated by: Bio Products Laboratory

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

An open, multi-centre study in patients with von Willebrand Disease (VWD) undergoing surgery.

Study Overview

Status

Terminated

Conditions

Von Willebrand Disease

Intervention / Treatment

Drug: Optivate

Study Type

Interventional

Enrollment (Anticipated)

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Israel
- - Haifa, Israel, 31096
    - Rambam Health Care Campus, 8 Haaliya St., Bat-Galim
  - Jerusalem, Israel, 91120
    - Haddasah Ein-Karem Medical Center, P.O.Box 12000
  - Petah Tikva, Israel, 49100
    - Beilinson Hospital, Rabin Medical Center, 39 Jabotinsky Street
United Kingdom
- - London, United Kingdom, NW2 3QG
    - Katharine Dormandy Haemophilia Centre and Haemostasis Unit, Royal Free Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Have given written informed consent.
Be aged 12 years or older.
Have VWD of known type.
Be due to undergo surgery, in which the investigator believes a VWF concentrate will be required.
Have a known lack of, poor response to, or contraindication to, DDAVP, or require a type of surgery in which a plasma-derived product is appropriate.
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 other modes of delivery, including normal vaginal 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.

Exclusion Criteria:

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). A result at screening is not mandatory if the patient is to undergo emergency surgery and the local laboratory is unable to perform the analyses.
Patients with thrombocytopenia (platelets <50 x 109/L).
Patients who have clinically significant renal disease (creatinine >200 µmol/L).
Patients who have clinically significant liver disease (ALT levels greater than three times the upper limit of the reference range).
Presence of any other major systemic illnesses which would compromise the outcome of the study in the opinion of the investigator.
Known or suspected hypersensitivity to investigational medicinal product (IMP) or its excipients.
Have a recent history of alcohol or drug abuse.
Administration of a new chemical entity within the 4 months preceding enrolment.
Participation in any other clinical study in which investigational or marketed drugs were employed in the 30 days preceding enrolment (screening visit) into this study, with the exception of the BPL clinical study Protocol 8VWF01.
Female patients who are lactating.
In the opinion of the investigator, the patient is unlikely to comply with the study protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
A subjective overall assessment by the investigator of OPTIVATE® in the control of bleeding due to surgery throughout the whole study. Time Frame: Throughout the whole study	Throughout the whole study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bio Products Laboratory

Investigators

Principal Investigator: Thynn Thynn Yee, Royal Free Hospital NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Sponsor's homepage

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

November 27, 2006

First Submitted That Met QC Criteria