Last reviewed · How we verify

NCT03511820

A Post Marketing Surveillance Study of Lipo-AB® (Amphotericin B) in Neutropenic Patients With Persistent Fever

Completed Last updated 30 April 2018
What this trial tests

trial testing Lipo-AB® (amphotericin B) liposome in Neutropenia, Febrile in 54 participants. Completed in 15 January 2018.

Timeline
24 May 2016
Primary endpoint
15 January 2018
15 January 2018

Quick facts

Lead sponsorTTY Biopharm
StatusCompleted
Study typeOBSERVATIONAL
Enrollment54
Start date24 May 2016
Primary completion15 January 2018
Estimated completion15 January 2018
Sites9 locations across Taiwan

Drugs / interventions tested

Conditions studied

Sponsor

TTY Biopharm — full company profile →

Who can join

Eligibility, any sex, with Neutropenia, Febrile. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Amphotericin B is a polyene antifungal drug used for the treatment of many systemic fungal infections. It is associated with many side effects which in some cases can be very severe and potentially lethal. Lipo-AB® is a true single bilayer liposomal drug delivery system, consisting of unilamellar bilayer liposomes with amphotericin B intercalated within the membrane. Prior studies showed that the liposomal formulation of amphotericin B greatly reduces the side effects of the parent drug, such as nephrotoxicity. This study is designed to evaluate the safety and efficacy of Lipo-AB® in neutropenic patients with persistent fever in routine clinical practice in Taiwan. 1. Primary objective: • To evaluate the nephrotoxicity of Lipo-AB® (amphotericin B) treatment in neutropenic patients with persistent fever in Taiwan clinical practice. 2. Secondary objectives: (1) To evaluate the safety profile of Lipo-AB® (amphotericin B) in neutropenic patients with persistent fever in Taiwan clinical practice. (2) To evaluate the treatment efficacy of Lipo-AB® (amphotericin B) in neutropenic patients with persistent fever in Taiwan clinical practice.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Inorganic Nanoparticles: Tools to Emphasize the Janus Face of Amphotericin B.
    Boudier A, Mammari N, Lamouroux E, Duval RE. · · 2023 · cited 1× · PMID 37887244 · DOI 10.3390/antibiotics12101543

Verify or expand the search:

Other TTY Biopharm trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03511820.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing