Ignite Creation Date:
2025-12-24 @ 1:42 PM
Ignite Modification Date:
2025-12-25 @ 12:37 PM
Study NCT ID:
NCT01063595
Status:
COMPLETED
Last Update Posted:
2014-05-20
First Post:
2010-02-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Trial to Investigate the Relative Efficacy, Safety, and Tolerability of Octaplas LG Versus Octaplas SD
Sponsor:
Octapharma
Organization:
Study Overview
Official Title:
A Comparative, Open-label, Randomized, Cross-over Phase I Trial in Healthy Volunteers to Investigate the Relative Efficacy, Safety and Tolerability of Octaplas LG™ vs. Octaplas®
Status:
COMPLETED
Status Verified Date:
2014-05
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 primary objective of the study was to compare the efficacy of Octaplas LG with Octaplas SD in terms of recovery of coagulation factors and other haemostatic parameters. The secondary objective of the study was to compare the safety and tolerability of Octaplas LG with Octaplas SD in terms of haematological and clinical chemistry parameters and adverse event monitoring.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: