Clinical trial NCT00404300: Optivate in People With Von Willebrand Disease Undergoing Surgery
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Von Willebrand Disease
Lead sponsor: Bio Products Laboratory
Sponsor class: OTHER
First posted: 2006-11-28
Enrollment: 25
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: A subjective overall assessment by the investigator of OPTIVATE® in the control of bleeding due to surgery throughout the whole study.
timeFrame: Throughout the whole study
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus, 8 Haaliya St., Bat-Galim
city: Jerusalem
country: Israel
facility: Haddasah Ein-Karem Medical Center, P.O.Box 12000
city: Petah Tikva
country: Israel
facility: Beilinson Hospital, Rabin Medical Center, 39 Jabotinsky Street
city: London
country: United Kingdom
facility: Katharine Dormandy Haemophilia Centre and Haemostasis Unit, Royal Free Hospital
Study officials:
affiliation: Royal Free Hospital NHS Foundation Trust
name: Thynn Thynn Yee
role: PRINCIPAL_INVESTIGATOR
References: