Optivate in People With Von Willebrand Disease Undergoing Surgery

Von Willebrand Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00404300
• Other study ID #: 8VWF03
• Status: Terminated
• Phase: Phase 3
• First received: November 27, 2006
• Last updated: March 2, 2010
• Start date: February 2007
• Est. completion date: September 2008

Study information

• Verified date: March 2010
• Source: Bio Products Laboratory
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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, poor response to, or contraindication to, DDAVP, or require a 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.

7. 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:

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). 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.

2. Patients with thrombocytopenia (platelets <50 x 109/L).

3. Patients who have clinically significant renal disease (creatinine >200 µmol/L).

4. Patients who have clinically significant liver disease (ALT levels greater than three times the upper limit of the reference range).

5. Presence of any other major systemic illnesses which would compromise the outcome of the study in the opinion of the investigator.

6. Known or suspected hypersensitivity to investigational medicinal product (IMP) or its excipients.

7. Have a recent history of alcohol or drug abuse.

8. Administration of a new chemical entity within the 4 months preceding enrolment.

9. 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.

10. Female patients who are lactating.

11. In the opinion of the investigator, the patient is unlikely to comply with the study protocol.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Von Willebrand Disease
• Von Willebrand Diseases

Intervention

Drug:
• Optivate
Plasma-derived Factor VIII

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Bio Products Laboratory

Countries where clinical trial is conducted

Israel,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A subjective overall assessment by the investigator of OPTIVATE® in the control of bleeding due to surgery throughout the whole study.		Throughout the whole study

External Links

•   Sponsor's homepage