Optivate in People With Von Willebrand Disease Undergoing Surgery
Primary Purpose
Von Willebrand Disease
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Optivate
Sponsored by
About this trial
This is an interventional treatment trial for Von Willebrand Disease
Eligibility Criteria
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.
Sites / Locations
- Rambam Health Care Campus, 8 Haaliya St., Bat-Galim
- Haddasah Ein-Karem Medical Center, P.O.Box 12000
- Beilinson Hospital, Rabin Medical Center, 39 Jabotinsky Street
- Katharine Dormandy Haemophilia Centre and Haemostasis Unit, Royal Free Hospital
Outcomes
Primary Outcome Measures
A subjective overall assessment by the investigator of OPTIVATE® in the control of bleeding due to surgery throughout the whole study.
Secondary Outcome Measures
Full Information
NCT ID
NCT00404300
First Posted
November 27, 2006
Last Updated
March 2, 2010
Sponsor
Bio Products Laboratory
1. Study Identification
Unique Protocol Identification Number
NCT00404300
Brief Title
Optivate in People With Von Willebrand Disease Undergoing Surgery
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Terminated
Why Stopped
Due to slow recruitment and a delay in reaching the recruitment target.
Study Start Date
February 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bio Products Laboratory
4. Oversight
5. Study Description
Brief Summary
An open, multi-centre study in patients with von Willebrand Disease (VWD) undergoing surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Von Willebrand Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Optivate
Intervention Description
Plasma-derived Factor VIII
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thynn Thynn Yee
Organizational Affiliation
Royal Free Hospital NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam Health Care Campus, 8 Haaliya St., Bat-Galim
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Haddasah Ein-Karem Medical Center, P.O.Box 12000
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Beilinson Hospital, Rabin Medical Center, 39 Jabotinsky Street
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Katharine Dormandy Haemophilia Centre and Haemostasis Unit, Royal Free Hospital
City
London
ZIP/Postal Code
NW2 3QG
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
http://www.bpl.co.uk
Description
Sponsor's homepage
Learn more about this trial
Optivate in People With Von Willebrand Disease Undergoing Surgery
We'll reach out to this number within 24 hrs