Optivate in People With Von Willebrand Disease Undergoing Surgery

NCT00404300 | Terminated Phase 3

• 1 other identifier: 8VWF03
• Study Type: interventional
• Target: 25
• Locations: 2 countries
• Sites: 4

Brief Summary

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

Conditions

Von Willebrand Disease

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Optivate DRUG

Plasma-derived Factor VIII

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bio Products Laboratory: lead

Study Sites (4)

Rambam Health Care Campus, 8 Haaliya St., Bat-Galim

Haifa, 31096, Israel

Location

Haddasah Ein-Karem Medical Center, P.O.Box 12000

Jerusalem, 91120, Israel

Location

Beilinson Hospital, Rabin Medical Center, 39 Jabotinsky Street

Petah Tikva, 49100, Israel

Location

Katharine Dormandy Haemophilia Centre and Haemostasis Unit, Royal Free Hospital

London, NW2 3QG, United Kingdom

Location

Related Links

• Sponsor's homepage

MeSH Terms

Conditions

von Willebrand Diseases

Interventions

optivate

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Blood Platelet Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Thynn Thynn Yee

  Royal Free Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 27, 2006
• First Posted: November 28, 2006
• Study Start: February 1, 2007
• Study Completion: September 1, 2008
• Last Updated: March 3, 2010

Record last verified: 2010-03

Locations

GB (1); IL (3)