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Completed

NCT Number: NCT03641131

Ampholipad Real-World Data in Taiwan

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

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Key information

Conditions

Aspergillus Infection Agranulocytosis Aspergillosis Bacterial Infections and Mycoses Candida Infection Candidiasis Cryptococcal Infections Cytopenia Febrile Neutropenia Fungal Infection Hematologic Diseases Hemic and Lymphatic Diseases Infections Leukocyte Disorders Leukopenia Mycoses Neutropenia

Age range

2 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shuang Ho Hospital, New Taipei City, Taiwan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female ≥ 2 years of age
  • 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

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

Taiwan Liposome Company

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 21, 2018
Registry last updated
Jan 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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