Ampholipad Real-World Data in Taiwan

Taiwan Liposome Company (TLC)

Status: Completed

Conditions: Fungal Infection; Candida Infection; Cryptococcal Infections; Febrile Neutropenia; Aspergillus Infection

Study type: Observational

Funder types: Industry

Identifiers

NCT03641131

TLC166B4013

Details and patient eligibility

About

A retrospective, post-marketing, multi-center chart review study includes patients who had been prescribed Ampholipad.

Full description

A retrospective, post-marketing, multi-center chart review study includes patients who had been prescribed Ampholipad in selected sentinel hospitals in Taiwan. Medical charts of approximately 100 treated patients will be reviewed by the investigators to collect the pre-specified data, including indication, underlying cancer type (only for cancer patients), demographics, and concomitant medications as well as all the laboratory examination data regarding renal function from 1 month prior to first dose of Ampholipad up to 1 week after the last dose of the initial treatment course.

Enrollment: 102 patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female ≥ 2 years of age
2. Patients who had received at least one dose of Ampholipad treatment, with available baseline serum creatinine (SCr) data within 1 month prior to first Ampholipad use and at least one post baseline SCr data during treatment period

Exclusion criteria

1. Patients whose medical chart cannot provide both the start and stop dates of Ampholipad for a course of treatment (first course only)
2. Patients who had documented HIV infection diagnosis
3. Patients with potential end-stage renal disease (ESRD) receiving regular dialysis within 1 month prior to first Ampholipad use