Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00074620
Status:
COMPLETED
Last Update Posted:
2007-10-05
First Post:
2003-12-17
Brief Title:
A Clinical Study to Assess the Safety of PEG-Hirudin SPP200 Compared to Heparin in Patients Who Are on Haemodialysis
Sponsor:
Speedel Pharma Ltd
Organization:
Speedel Pharma Ltd
Study Overview
Official Title:
A Randomised Multicenter Open-Label Parallel Group Study to Assess the Safety of PEG-Hirudin SPP200 Compared to Unfractionated Heparin as Anticoagulant Treatment in Patients Undergoing Haemodialysis Via an Arteriovenous Graft
Status:
COMPLETED
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study will look at the safety profile unwanted effects of the long-lasting anticoagulant PEG-hirudin SPP200 and compare these unwanted effects to those of unfractionated heparin commonly used in haemodialysis to avoid clotting of the graft and of the haemodialysis machine
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