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Optivate in People With Von Willebrand Disease Undergoing Surgery

This study is currently recruiting participants.
Verified by Bio Products Laboratory, November 2007

Sponsored by: Bio Products Laboratory
Information provided by: Bio Products Laboratory
ClinicalTrials.gov Identifier: NCT00404300
  Purpose

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


Condition Intervention Phase
Von Willebrand Disease
Drug: Optivate
Phase III

Genetics Home Reference related topics:   hemophilia    von Willebrand disease   

ChemIDplus related topics:   Factor VIII    Octocog alfa   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Bio Products Laboratory:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment:   25
Study Start Date:   February 2007
Estimated Study Completion Date:   February 2008

Intervention Details:
    Drug: Optivate
    Plasma-derived Factor VIII
  Eligibility
Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00404300

Contacts
Contact: Steven Morley     +44(0) 1423 816594     morley.steve@kendle.com    

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

Sponsors and Collaborators
Bio Products Laboratory

Investigators
Principal Investigator:     Thynn Thynn Yee     Royal Free Hospital    
  More Information


Sponsor's homepage  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   8VWF03
First Received:   November 27, 2006
Last Updated:   November 9, 2007
ClinicalTrials.gov Identifier:   NCT00404300
Health Authority:   United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:
Von Willebrand Disease
Thrombocytopathy
Hemorrhagic Disorders
Genetic Diseases, Inborn
Hematologic Diseases
Blood Platelet Disorders
Blood Coagulation Disorders
Hemostatic Disorders
Von Willebrand disease
Factor VIII

Additional relevant MeSH terms:
Blood Coagulation Disorders, Inherited
Coagulation Protein Disorders

ClinicalTrials.gov processed this record on September 23, 2008




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