drugset / Trial / NCT00074620

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

NCT00074620 ↗

Phase 2 Completed 260 enrolled Speedel Pharma Ltd. Quintiles, Inc. · collab
RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2003-11
Primary completion
—
Completion
2006-01

Drugs

EvaluationDrugModalityDoseRoute
Subject PEGMUSIRUDIN Protein / enzyme biologic — —