Ampholipad Real-World Data in Taiwan

January 5, 2021 updated by: Taiwan Liposome Company

A Retrospective, Post-Marketing, Sentinel-based Active Surveillance Study to Evaluate the Safety of Ampholipad Using Real-World Data in Taiwan

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

102

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • New Taipei City, Taiwan
        • Shuang Ho Hospital
      • Taichung, Taiwan
        • Taichung Veterans General Hospital
      • Taichung, Taiwan
        • Chung Shan Medical University Hospital
      • Tainan, Taiwan
        • Chi Mei Hospital
      • Taipei, Taiwan
        • Taipei Municipal Wanfang Hospital
      • Taipei, Taiwan
        • Tri Service General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who had received at least one dose of Ampholipad treatment in Taiwan

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of nephrotoxicity
Time Frame: 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
Ampholipad treatment course, up to 42 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of SCr >1.5X, SCr >2X or SCr >3X of the baseline values
Time Frame: 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
From 1 month prior to first dose of Ampholipad up to 1 week after the last dose of the initial treatment course
Incidence of Adverse Drug Reaction (ADR)
Time Frame: 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
From 1 month prior to first dose of Ampholipad up to 1 week after the last dose of the initial treatment course
eGFR
Time Frame: 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
From 1 month prior to first dose of Ampholipad up to 1 week after the last dose of the initial treatment course
Survival rate
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
From 1 month prior to first dose of Ampholipad up to 1 week after the last dose of the initial treatment course

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taiwan Liposome Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 9, 2018

Primary Completion (ACTUAL)

January 2, 2019

Study Completion (ACTUAL)

January 8, 2019

Study Registration Dates

First Submitted

August 14, 2018

First Submitted That Met QC Criteria

August 20, 2018

First Posted (ACTUAL)

August 21, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 7, 2021

Last Update Submitted That Met QC Criteria

January 5, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TLC166B4013

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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