NCT05108545

A Study of Amphotericin B Liposome for Injection in Patients With Persistent Neutropenia and Fever

A Multicenter, Open-label, Phase Ⅲ Study to Evaluate the Efficacy and Safety of Amphotericin B Liposome for Injection in Patients With Persistent Febrile Neutropenia

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 93 (estimated)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label, single-arm, phase III study to evaluate the safety and efficacy of Amphotericin B liposomes in patients with persistent neutropenia and fever.

Detailed description

This is a multicenter, open-label, single-arm, phase III study to evaluate the safety and efficacy of Amphotericin B liposomes in patients with persistent neutropenia and fever. About 93 patients will be recruited in this study. The patients will receive Amphotericin B liposomes intravenous infusion at a dose of 3 mg/kg over 2 hours once daily (qd) for a maximum of 12 weeks.

Conditions

• Neutropenia and Fever

Interventions

Type	Name	Description
DRUG	Amphotericin B liposomes	Amphotericin B liposomes for injection, 3 mg/kg, qd, IV

Timeline

• Start date: 2021-12-15
• Primary completion: 2022-07-31
• Completion: 2023-01-15
• First posted: 2021-11-05
• Last updated: 2021-11-05