Efficacy and Safety of CUSA-081 in the Restoration of Central Venous Access Device (CVAD) Functionality

Summary

To evaluate the efficacy and safety of CUSA-081 (diluted reteplase) in the restoration of central venous access device (CVAD) functionality in participants 18 years and older.

Timeline

Start

2020-02-12

Primary completion

2023-06-08

Completion

2023-07-10

Outcome

Met primary endpoint

Stopped (Enrollment): “Due to ongoing recruitment challenges globally, it is not possible to complete this study. The decision is not based on any reported changes in the safety profile or any concerns with the anticipated efficacy profile of the investigational product.”

registry analysis (superiority test); CUSA-081 vs Placebo; p = 0.003; Mean difference of proportions, Wald 29.51 (95% CI 10.76 to 48.26) NCT03594175 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Alteplase	Protein / enzyme biologic	2 mg/ml	Other
Subject	CUSA-081	Protein / enzyme biologic	0.7 mg	Other

Indications