Optivate in People With Von Willebrand Disease Undergoing Surgery

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00404300
• Date of registration: 27/11/2006
• Prospective Registration: Yes
• Primary sponsor: Bio Products Laboratory
• Public title: Optivate in People With Von Willebrand Disease Undergoing Surgery
• Scientific 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
• Date of first enrolment: February 2007
• Target sample size: 25
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00404300
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Israel, United Kingdom

Contacts

• Name: Thynn Thynn Yee
• Affiliation: Royal Free Hospital NHS Foundation Trust

Key inclusion & exclusion 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.



Age minimum: 12 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Von Willebrand Disease

Intervention(s)

Drug: Optivate

Primary Outcome(s)

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]

Secondary ID(s)

8VWF03

Source(s) of Monetary Support

Please refer to primary and secondary sponsors