drugset / Trial / NCT05145283
Recombinant Human C1 Esterase Inhibitor (Conestat Alfa) in the Prevention of Acute Ischemic Cerebral and Renal Events After Transcatheter Aortic Valve Implantation
Phase 2
Completed
141 enrolled
University Hospital, Basel, Switzerland
Pharming Technologies B.V. · collabSwiss National Science Foundation · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
The aim of this trial is to assess the safety and efficacy of conestat alfa (Ruconest®, Pharming Technologies B.V.) on renal and cerebral ischemic events in patients undergoing TAVI for severe symptomatic aortic stenosis (AS) compared to placebo.
Timeline
- Start
- 2022-03-16
- Primary completion
- 2026-01-05
- Completion
- 2026-01-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | recombinant human C1 inhibitor | Protein / enzyme biologic | 50 iu/kg | Intravenous |
| Comparator | recombinant human C1 inhibitor | Protein / enzyme biologic | 4200 iu | Intravenous |