drugset / Trial / NCT02215824
Investigation of Safety, Pharmacokinetics and Pharmacodynamics of Different Doses of BIWH 3 in Patients With Chronic Critical Limb Ischaemia
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |