Back to resultsA Study to Compare the Pharmacokinetics and Safety of Optivate® and Haemate P® in Patients With Von Willebrand Disease.
Primary Purpose
vonWillebrand's Disease
Status
Completed
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Optivate® (Human Coagulation Factor VIII)
Haemate P® (Human Coagulation Factor VIII)
Sponsored by
About this trial
This is an interventional treatment trial for vonWillebrand's Disease
Eligibility Criteria
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:
-
Sites / Locations
- Hematology Dept., Sackler School of Medicine, Tel Aviv University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Optivate®
Haemate P®
Arm Description
Outcomes
Primary Outcome Measures
AUC (0-48h) for VWF: RCo
Secondary Outcome Measures
Full Information
NCT ID
NCT02250508
First Posted
September 2, 2014
Last Updated
February 14, 2018
Sponsor
Bio Products Laboratory
1. Study Identification
Unique Protocol Identification Number
NCT02250508
Brief Title
A Study to Compare the Pharmacokinetics and Safety of Optivate® and Haemate P® in Patients With Von Willebrand Disease.
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bio Products Laboratory
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
vonWillebrand's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
8. Arms, Groups, and Interventions
Arm Title
Optivate®
Arm Type
Experimental
Arm Title
Haemate P®
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Optivate® (Human Coagulation Factor VIII)
Intervention Type
Biological
Intervention Name(s)
Haemate P® (Human Coagulation Factor VIII)
Primary Outcome Measure Information:
Title
AUC (0-48h) for VWF: RCo
Time Frame
Pre-dose, 30 min, 1, 2, 5, 8, 24, 48 hours post-dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
-
Facility Information:
Facility Name
Hematology Dept., Sackler School of Medicine, Tel Aviv University
City
Tel Aviv
Country
Israel
12. IPD Sharing Statement
Links:
URL
http://www.bpl.co.uk
Description
Related Info
Learn more about this trial
A Study to Compare the Pharmacokinetics and Safety of Optivate® and Haemate P® in Patients With Von Willebrand Disease.
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