Optivate in People With Von Willebrand Disease Undergoing Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2008-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study With OPTIVATE® in People With Von Willebrand Disease

NCT00387192

Von Willebrand Disease

TERMINATED PHASE3

An Open Study to Investigate the Safety and Efficacy of Optivate® in Haemophilia A Patients Undergoing Surgery.

NCT02250482

Haemophilia A

COMPLETED PHASE3

A Study to Compare the Pharmacokinetics and Safety of Current Factor VIII Concentrate and Optivate® in Haemophilia A.

NCT02246881

Von Willebrand Disease

COMPLETED PHASE3

A Study to Compare the Pharmacokinetics and Safety of Optivate® and Haemate P® in Patients With Von Willebrand Disease.

NCT02250508

vonWillebrand's Disease

COMPLETED PHASE2

An Open Study to Investigate the Safety and Efficacy of Optivate® in Severe Haemophilia A Patients.

NCT02246868

Haemophilia A

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Von Willebrand Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Optivate

Plasma-derived Factor VIII

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No