drugset / Trial / NCT01958164
Efficacy and Safety of Actilyse 2 mg/ 2 ml in Comparison to Saline Solution in Patients With Central Venous Access Device Occlusion
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a multicentre, open-label, randomised, phase III study designed to evaluate the efficacy and safety of Actilyse 2 mg/2 ml in the restoration of function of CVAD
Timeline
- Start
- 2013-09
- Primary completion
- 2014-04
- Completion
- 2014-04
Outcome
Met primary endpoint
registry analysis (superiority or other test); Actilyse vs Saline Solution + Actilyse; Mean Difference (Net) 73.3 (95% CI 23.3 to 89.3) NCT01958164 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alteplase | Protein / enzyme biologic | 2 mg | Other |
Indications
No indication recorded.