Ignite Creation Date:
2024-05-06 @ 3:17 AM
Last Modification Date:
2024-10-26 @ 11:31 AM
Study NCT ID:
NCT02250508
Status:
COMPLETED
Last Update Posted:
2018-02-15
First Post:
2014-09-02
Brief Title:
A Study to Compare the Pharmacokinetics and Safety of Optivate and Haemate P in Patients With Von Willebrand Disease
Sponsor:
Bio Products Laboratory
Organization:
Bio Products Laboratory
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 VWFAg VWFCBA and Factor VIII assays
to compare the clinical tolerance and safety of these two treatments after single IV infusions in subjects with VWD
to compare the pharmacokinetics PK of Optivate and Haemate P in various types of vonWillebrand disease VWD using the results from the VWF RCo VWFAg VWFCBA and Factor VIII assays
to compare the clinical tolerance and safety of these two treatments after single IV infusions in subjects with VWD
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None