NCT03641131

Ampholipad Real-World Data in Taiwan

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 102 (actual)
• Sponsor: Taiwan Liposome Company · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aspergillus Infection
• Febrile Neutropenia
• Candida Infection
• Fungal Infection
• Cryptococcal Infections

Timeline

• Start date: 2018-09-09
• Primary completion: 2019-01-02
• Completion: 2019-01-08
• First posted: 2018-08-21
• Last updated: 2021-01-07

Locations

6 sites across 1 country: Taiwan