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NCT03511820
A Post Marketing Surveillance Study of Lipo-AB® (Amphotericin B) in Neutropenic Patients With Persistent Fever
trial testing Lipo-AB® (amphotericin B) liposome in Neutropenia, Febrile in 54 participants. Completed in 15 January 2018.
15 January 2018
Quick facts
| Lead sponsor | TTY Biopharm |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 54 |
| Start date | 24 May 2016 |
| Primary completion | 15 January 2018 |
| Estimated completion | 15 January 2018 |
| Sites | 9 locations across Taiwan |
Drugs / interventions tested
- Lipo-AB® (amphotericin B) liposome — full drug profile →
Conditions studied
- Neutropenia, Febrile — all drugs for Neutropenia, Febrile →
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):
-
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:
- PubMed search for NCT03511820
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other TTY Biopharm trials
Trials by the same sponsor.
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- NCT05359627 — A Pharmacokinetic Study of Polymyxin B in Healthy Subjects and Subjects With Renal Insufficiency · Phase 1 · completed
- NCT04070313 — A Phase II Study of S-1 Adjuvant Chemotherapy in Patients With Resected Pancreatic Cancer in Taiwan · Phase 2 · terminated
- NCT03517618 — TS-1 in Combination With Calcium Folinate in Patients With Heavily Pre-treated mCRC · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03511820 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by TTY Biopharm
- Last refreshed: 30 April 2018
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