NCT03511820

A Post Marketing Surveillance Study of Lipo-AB® (Amphotericin B) in Neutropenic Patients With Persistent Fever

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 54 (actual)
• Sponsor: TTY Biopharm · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Amphotericin B is a polyene antifungal drug used for the treatment of many systemic fungal infections. It is associated with many side effects which in some cases can be very severe and potentially lethal. Lipo-AB® is a true single bilayer liposomal drug delivery system, consisting of unilamellar bilayer liposomes with amphotericin B intercalated within the membrane. Prior studies showed that the liposomal formulation of amphotericin B greatly reduces the side effects of the parent drug, such as nephrotoxicity. This study is designed to evaluate the safety and efficacy of Lipo-AB® in neutropenic patients with persistent fever in routine clinical practice in Taiwan. 1. Primary objective: • To evaluate the nephrotoxicity of Lipo-AB® (amphotericin B) treatment in neutropenic patients with persistent fever in Taiwan clinical practice. 2. Secondary objectives: (1) To evaluate the safety profile of Lipo-AB® (amphotericin B) in neutropenic patients with persistent fever in Taiwan clinical practice. (2) To evaluate the treatment efficacy of Lipo-AB® (amphotericin B) in neutropenic patients with persistent fever in Taiwan clinical practice.

Conditions

• Neutropenia, Febrile

Interventions

Type	Name	Description
DRUG	Lipo-AB® (amphotericin B) liposome	1. Name: Lipo-AB® (amphotericin B) liposome for injection 2. Dosage form: Lyophilized powder 50 mg/vial 3. Dose: Based on approved package insert and physician's discretion Recommended initial dose: 3 mg/kg/day 4. Dosing schedule: All patients will receive Lipo-AB® based on the approved package insert and physician's clinical decision.

Timeline

• Start date: 2016-05-24
• Primary completion: 2018-01-15
• Completion: 2018-01-15
• First posted: 2018-04-30
• Last updated: 2018-04-30

Locations

9 sites across 1 country: Taiwan