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A Study With OPTIVATE® in People With Von Willebrand Disease

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: NCT00387192
Recruitment Status : Terminated (Due to slow recruitment and a significant delay in reaching the recruitment target.)
First Posted : October 12, 2006
Last Update Posted : March 3, 2010
Information provided by:
Bio Products Laboratory

Brief Summary:
The main objective of the study is to assess the pharmacokinetics of OPTIVATE® after a single dose of 80 IU/kg VWF:RCo. The secondary objectives of the study are to assess efficacy and safety of OPTIVATE® in long-term use over at least 12 months.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Multi-centre Study in Patients With Von Willebrand Disease to Investigate the Pharmacokinetics, Efficacy and Safety of OPTIVATE®, a High Purity, Dual Inactivated Factor VIII and Von Willebrand Factor Concentrate
Study Start Date : November 2006
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. Pharmacokinetic parameters for VWF RCo at the Baseline Visit by VWD type and overall. [ Time Frame: Baseline vist ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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 severe VWD (VWF:RCo <20%) of known type. Severity will be confirmed by a current VWF:RCo result of <20%.
  4. Be known or expected to require a concentrate for management of VWD.
  5. Must have had at least one bleed in the last 12 months which required treatment with a FVIII and VWF concentrate.
  6. Have a known lack of, or poor response to, DDAVP.
  7. Have a prothrombin time (PT) of not more than 3 seconds above the upper limit of the reference range.
  8. At the Baseline Visit (Visit 1), patients must have had at least 5 days since their last infusion of replacement factor concentrate or DDAVP.
  9. Female patients of child-bearing potential 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. Female patients must not be lactating.

Exclusion Criteria:

  1. Have a history of inhibitor development to VWF or FVIII or a positive result at screening.
  2. Actively bleeding (Note: the patient can enter the study once the bleed is controlled).
  3. Presence of major systemic illnesses: renal disease, liver disease, or neurological or psychiatric disease which would compromise the outcome of the study in the opinion of the investigator.
  4. Known or suspected hypersensitivity to investigational medicinal product (IMP) or its excipients.
  5. Have a recent history of alcohol or drug abuse.
  6. Administration of a new chemical entity within the 4 months preceding enrolment.
  7. Participation in any other clinical study in which investigational or marketed drugs were employed in the 30 days preceding enrolment into this study, with the exception of the BPL clinical study Protocol 8VWF03.
  8. 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): NCT00387192

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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 Jabontinsky Street
Petah Tikva, Israel, 49100
United Kingdom
University Department of Haematology
Manchester, United Kingdom, M13 9WL
Sponsors and Collaborators
Bio Products Laboratory
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Principal Investigator: Charles Hay, MD Manchester Haemophilia Comprehensive Care Centre
Additional Information:
Layout table for additonal information Identifier: NCT00387192    
Other Study ID Numbers: 8VWF01
First Posted: October 12, 2006    Key Record Dates
Last Update Posted: March 3, 2010
Last Verified: March 2010
Keywords provided by Bio Products Laboratory:
Von Willebrand Disease
Factor VIII
Von Willebrand Factor
Additional relevant MeSH terms:
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Von Willebrand Diseases
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Blood Platelet Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn