Ampholipad Real-World Data in Taiwan

Completed

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

• Registration Number: NCT03641131
• Lead Sponsor: Taiwan Liposome Company

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2018-08-14
• Study First Submitted QC: 2018-08-20
• Study First Posted: 2018-08-21
• Study Start: 2018-09-09
• Primary Completion: 2019-01-02
• Study Completion: 2019-01-08
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-05
• Last Update Posted: 2021-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of nephrotoxicity	Ampholipad treatment course, up to 42 days	Nephrotoxicity is defined as an increase in serum creatinine (SCr) to \>2X baseline value and the post-baseline peak SCr \> 1.2 mg/dL

Secondary Outcome Measures

Name	Time	Method
Incidence of Adverse Drug Reaction (ADR)	From 1 month prior to first dose of Ampholipad up to 1 week after the last dose of the initial treatment course	Number of ADRs reported/collected during the protocol-defined retrospective medical chart review period
eGFR	From 1 month prior to first dose of Ampholipad up to 1 week after the last dose of the initial treatment course	Changes in estimated glomerular filtration rate (eGFR) from baseline throughout the Ampholipad treatment period
Proportion of SCr >1.5X, SCr >2X or SCr >3X of the baseline values	From 1 month prior to first dose of Ampholipad up to 1 week after the last dose of the initial treatment course	Incidence of SCr \>1.5X, SCr \>2X or SCr \>3X of the baseline values
Fever resolution rate	From 1 month prior to first dose of Ampholipad up to 1 week after the last dose of the initial treatment course	Fever resolution rate of Ampholipad treatment in febrile neutropenic patients
Survival rate	From 1 month prior to first dose of Ampholipad up to 1 week after the last dose of the initial treatment course	Survival rate through 7 days after the last day of the Ampholipad treatment
Microbiological eradication rate	From 1 month prior to first dose of Ampholipad up to 1 week after the last dose of the initial treatment course	Microbiological eradication rate of Ampholipad treatment

Trial Locations

Locations (6)

Taipei Municipal Wanfang Hospital; 🇨🇳 Taipei, Taiwan

Chi Mei Hospital; 🇨🇳 Tainan, Taiwan

Tri Service General Hospital; 🇨🇳 Taipei, Taiwan

Shuang Ho Hospital; 🇨🇳 New Taipei City, Taiwan

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan

Chung Shan Medical University Hospital; 🇨🇳 Taichung, Taiwan