A Clinical Study to Assess the Safety of PEG-Hirudin (SPP200) Compared to Heparin in Patients Who Are on Haemodialysis
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|ClinicalTrials.gov Identifier: NCT00074620|
Recruitment Status : Completed
First Posted : December 19, 2003
Last Update Posted : October 5, 2007
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Failure Vascular Graft Occlusion||Drug: PEG-hirudin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||260 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||November 2003|
|Study Completion Date :||January 2006|
- To determine the safety and tolerability of SPP200 in patients undergoing chronic haemodialysis via an arteriovenous graft.
- To determine the efficacy of PEG-hirudin compared to unfractionated heparin (UFH) on the frequency of vascular graft occlusions and on time to first graft occlusions.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00074620
|United States, Pennsylvania|
|Pennsylvania Hospital - Franklin Dialysis Center|
|Philadelphia, Pennsylvania, United States, 19106|
|Study Chair:||Jessica M Mann, MD, PhD||Speedel Bio Ltd|