Optivate in People With Von Willebrand Disease Undergoing Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00404300
Recruitment Status : Terminated (Due to slow recruitment and a delay in reaching the recruitment target.)
First Posted : November 28, 2006
Last Update Posted : March 3, 2010
Information provided by:
Bio Products Laboratory

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

Condition or disease Intervention/treatment Phase
Von Willebrand Disease Drug: Optivate Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2007
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: Optivate
    Plasma-derived Factor VIII

Primary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00404300

Rambam Health Care Campus, 8 Haaliya St., Bat-Galim
Haifa, Israel, 31096
Haddasah Ein-Karem Medical Center, P.O.Box 12000
Jerusalem, Israel, 91120
Beilinson Hospital, Rabin Medical Center, 39 Jabotinsky Street
Petah Tikva, Israel, 49100
United Kingdom
Katharine Dormandy Haemophilia Centre and Haemostasis Unit, Royal Free Hospital
London, United Kingdom, NW2 3QG
Sponsors and Collaborators
Bio Products Laboratory
Principal Investigator: Thynn Thynn Yee Royal Free Hospital NHS Foundation Trust

Additional Information: Identifier: NCT00404300     History of Changes
Other Study ID Numbers: 8VWF03
First Posted: November 28, 2006    Key Record Dates
Last Update Posted: March 3, 2010
Last Verified: March 2010

Additional relevant MeSH terms:
Von Willebrand Diseases
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Blood Platelet Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Factor VIII