CUSA-081 (reteplase)
/ Chiesi
- LARVOL DELTA
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August 09, 2023
READY 1: Efficacy and Safety of CUSA-081 in the Restoration of Central Venous Access Device (CVAD) Functionality
(clinicaltrials.gov)
- P3 | N=462 | Terminated | Sponsor: Chiesi Farmaceutici S.p.A. | N=800 ➔ 462 | Trial completion date: Oct 2025 ➔ Jul 2023 | Recruiting ➔ Terminated | Trial primary completion date: Feb 2025 ➔ Jun 2023; 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.
Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Cardiovascular • Hematological Disorders • Thrombosis
April 15, 2022
READY 2: Efficacy and Safety of CUSA-081 in the Restoration of Dysfunctional Central Venous Access Device (CVAD) Functionality
(clinicaltrials.gov)
- P3 | N=0 | Withdrawn | Sponsor: Chiesi Farmaceutici S.p.A. | N=105 ➔ 0 | Trial completion date: Aug 2023 ➔ Mar 2022 | Not yet recruiting ➔ Withdrawn | Trial primary completion date: Jan 2023 ➔ Mar 2022
Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal
April 01, 2022
READY 1: Efficacy and Safety of CUSA-081 in the Restoration of Central Venous Access Device (CVAD) Functionality
(clinicaltrials.gov)
- P3 | N=800 | Recruiting | Sponsor: Chiesi Farmaceutici S.p.A. | Trial completion date: Sep 2022 ➔ Oct 2025 | Trial primary completion date: Aug 2022 ➔ Feb 2025
Trial completion date • Trial primary completion date • Cardiovascular • Hematological Disorders • Thrombosis
February 17, 2022
READY 2 is a Phase 3 study to evaluate the safety of up to two instillations of CUSA-081 for restoration of function to central venous access devices (CVADs)
(clinicaltrialsregister.eu)
- P3 | N=105 | Ongoing | Sponsor: Chiesi Farmaceutici S.p.A.
New P3 trial • Cardiovascular • Hematological Disorders • Thrombosis
October 01, 2021
READY 2: Efficacy and Safety of CUSA-081 in the Restoration of Dysfunctional Central Venous Access Device (CVAD) Functionality
(clinicaltrials.gov)
- P3; N=105; Not yet recruiting; Sponsor: Chiesi Farmaceutici S.p.A.; N=250 ➔ 105
Clinical • Enrollment change
April 23, 2021
READY 2: Efficacy and Safety of CUSA-081 in the Restoration of Dysfunctional Central Venous Access Device (CVAD) Functionality
(clinicaltrials.gov)
- P3; N=250; Not yet recruiting; Sponsor: Chiesi Farmaceutici S.p.A.; Trial completion date: May 2022 ➔ Aug 2023; Trial primary completion date: Apr 2022 ➔ Jan 2023
Clinical • Trial completion date • Trial primary completion date
April 23, 2021
READY 1: Efficacy and Safety of CUSA-081 in the Restoration of Central Venous Access Device (CVAD) Functionality
(clinicaltrials.gov)
- P3; N=800; Recruiting; Sponsor: Chiesi Farmaceutici S.p.A.; Trial completion date: Dec 2021 ➔ Sep 2022; Trial primary completion date: Nov 2021 ➔ Aug 2022
Clinical • Trial completion date • Trial primary completion date • Cardiovascular • Hematological Disorders • Thrombosis
October 19, 2020
READY 2: Efficacy and Safety of CUSA-081 in the Restoration of Dysfunctional Central Venous Access Device (CVAD) Functionality
(clinicaltrials.gov)
- P3; N=250; Not yet recruiting; Sponsor: Chiesi Farmaceutici S.p.A.; Trial completion date: Dec 2021 ➔ May 2022; Trial primary completion date: Nov 2021 ➔ Apr 2022
Clinical • Trial completion date • Trial primary completion date
January 21, 2020
READY 1: Efficacy and Safety of CUSA-081 in the Restoration of Central Venous Access Device (CVAD) Functionality
(clinicaltrials.gov)
- P3; N=800; Recruiting; Sponsor: Chiesi Farmaceutici S.p.A.; Not yet recruiting ➔ Recruiting
Clinical • Enrollment open
January 02, 2020
A study of CUSA-081 (reteplase) to evaluate its activity on clots with central venous access devices.
(clinicaltrialsregister.eu)
- P3; N=841; Ongoing; Sponsor: Chiesi Farmaceutici S.p.A.
Clinical • New P3 trial
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