A Clinical Study to Assess the Safety of PEG-Hirudin (SPP200) Compared to Heparin in Patients Who Are on Haemodialysis

• Status: Completed
• Trial end date: 2006-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Speedel Pharma Ltd.
• Collaborator: Quintiles, Inc.
• Treatments: Heparin; Hirudins

Criteria

• Patients undergoing chronic haemodialysis via an arteriovenous graft

• Arteriovenous graft in place for at least 3 months

• Duration of haemodialysis of at least 3 months, with 3 full dialysis sessions per week with a duration between 2 and 5 hours per session

• Women patients must be either postmenopausal for more than 1 year or, if of childbearing age, must use adequate contraception

• Women patients must have a negative serum pregnancy test within one week of randomisation

• Able to provide written informed consent prior to study participation