drugset / Trial / NCT02215824

Investigation of Safety, Pharmacokinetics and Pharmacodynamics of Different Doses of BIWH 3 in Patients With Chronic Critical Limb Ischaemia

NCT02215824 ↗

Phase 1 Terminated 7 enrolled Boehringer Ingelheim
RandomizedParallel-groupDouble-blindTreatment

Summary

The primary aim of this trial was to investigate the safety of a 6 hour intraarterial infusion of BIWH 3 (pyro-Glu-rhMCP-1) in patients with severe peripheral arterial occlusive disease (PAOD) and chronic Critical Limb Ischaemia (Fontaine class III or IV).

Timeline

Start
2002-10
Primary completion
2003-10
Completion
—

Drugs

EvaluationDrugModalityDoseRoute
Subject BIWH 3 Protein / enzyme biologic 0.2 ug Other
Subject BIWH 3 Protein / enzyme biologic 0.6 ug Other
Subject BIWH 3 Protein / enzyme biologic 2 ug Other
Subject BIWH 3 Protein / enzyme biologic 6 ug Other
Subject BIWH 3 Protein / enzyme biologic 20 ug Other