Trials / Completed
CompletedNCT00074620
A Clinical Study to Assess the Safety of PEG-Hirudin (SPP200) Compared to Heparin in Patients Who Are on Haemodialysis
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
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 260 (planned)
- Sponsor
- Speedel Pharma Ltd. · Industry
- Sex
- All
- Age
- 21 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PEG-hirudin |
Timeline
- Start date
- 2003-11-01
- Completion
- 2006-01-01
- First posted
- 2003-12-19
- Last updated
- 2007-10-05
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00074620. Inclusion in this directory is not an endorsement.