Ampholipad Real-World Data in Taiwan

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-09

Study Completion Date

2019-01-08

Brief Summary

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

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Detailed Description

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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.

Conditions

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Aspergillus Infection Febrile Neutropenia Candida Infection Fungal Infection Cryptococcal Infections

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No