- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02250508
A Study to Compare the Pharmacokinetics and Safety of Optivate® and Haemate P® in Patients With Von Willebrand Disease.
February 14, 2018 updated by: Bio Products Laboratory
A Randomised, Comparative, Single Dose, Open Study to Compare the Pharmacokinetics and Safety of Optivate® and Haemate P® in Patients With Different Types of Von Willebrand Disease.
The main objectives of the study were
- to compare the pharmacokinetics (PK) of Optivate® and Haemate P® in various types of vonWillebrand disease (VWD) using the results from the VWF: RCo, VWF:Ag, VWF:CBA and Factor VIII assays.
- to compare the clinical tolerance and safety of these two treatments after single IV infusions in subjects with VWD.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tel Aviv, Israel
- Hematology Dept., Sackler School of Medicine, Tel Aviv University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Previously treated subjects of at least 12 years of age, with any type of VWD were eligible for entry into this study.
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Optivate®
|
|
Active Comparator: Haemate P®
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
AUC (0-48h) for VWF: RCo
Time Frame: Pre-dose, 30 min, 1, 2, 5, 8, 24, 48 hours post-dose
|
Pre-dose, 30 min, 1, 2, 5, 8, 24, 48 hours post-dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2004
Primary Completion (Actual)
June 1, 2005
Study Registration Dates
First Submitted
September 2, 2014
First Submitted That Met QC Criteria
September 24, 2014
First Posted (Estimate)
September 26, 2014
Study Record Updates
Last Update Posted (Actual)
February 15, 2018
Last Update Submitted That Met QC Criteria
February 14, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8VWF04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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