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Clinical Trials List

Protocol NumberTTYLA1201
NCT Number(ClinicalTrials.gov Identfier)NCT03511820

2015-06-30 - 2017-12-31

Phase IV

Terminated9

ICD-10D70.9

Neutropenia, unspecified

A post marketing surveillance study of Lipo-AB® (amphotericin B) in neutropenic patients with persistent fever

  • Trial Applicant

    TTY Biopharm Company Limited

  • Sponsor

    TTY Biopharm Company Limited

  • Trial scale

    Taiwan Multiple Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator 名Jung-Chung Lin Division of Infectious Disease
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Fu-Der Wang Division of Infectious Disease
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 黃協賢 Division of Infectious Disease
Chang Gung Medical Foundation Chang Gung Memorial Hospital, Keelung

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 馬銘君 Division of Hematology & Oncology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 林炫聿 Division of Hematology & Oncology
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Su-Peng Yeh Division of Hematology & Oncology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Susan Shin-Jung Lee Division of Infectious Disease
Kaohsiung Veterans General Hosptial

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Su-Peng Yeh 未分科
China Medical University Hospital-Taipei

Co-Principal Investigator

Audit

None

Principal Investigator Po-Nan Wang Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Audit

None

Principal Investigator Wen-Sen Lee Division of Infectious Disease
Taipei WanFang Hospital (Managed by Taipei Medical Univeristy)

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

10 Terminated

Audit

None

Condition/Disease

neutropenic

Objectives

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.

Test Drug

amphotericin B

Active Ingredient

Amphotericin B

Dosage Form

Injection

Dosage

3 mg/kg/day

Endpoints

1. Primary safety endpoint:
 Incidence rate of nephrotoxicity
* Nephrotoxicity is defined as serum creatinine (SCr) values increasing 100% or
more over pretreatment levels in pediatric patients, and creatinine values
increasing 100% or more over pretreatment levels in adult patients provided
the peak creatinine concentration was > 1.2 mg/dL during treatment period.
** The nephrotoxicity associated with baseline SCr will also be assessed.
2. Secondary safety endpoints:
(1) Categorization of the change in renal function
o SCr < 1.5 x baseline SCr (BSC)
o SCr ≥ 1.5 x BSC
o SCr ≥ 2 x BSC
o SCr ≥ 3 x BSC
(2) Change in laboratory parameters
(3) Change in vital signs
(4) Adverse event(s)
o Hypokalemia
* Defined as serum potassium level of < 2.5 mmol/L
o Hypomagnesemia
* Defined as serum magnesium level of < 0.5 mmol/L (or < 1.2 mg/dL)
o Hypocalcemia
* Defined as serum calcium level of < 2.0 mmol/L (or < 8.0 mg/dL)
o Hypernatremia
* Defined as serum sodium level of > 150 mmol/L
o Hyponatremia
* Defined as serum sodium level of < 130 mmol/L
o Infusion-related reaction(s) (IRR)
* Defined as any signs or symptoms experienced during infusion or within 1
hour after completion of the study infusion
- Fever (defined as TT increase ≥ 1.0°C)
* Proportion of subjects with TT increase ≥ 0.3°C will also be assessed.
- Chills/rigors
- Nausea
- Vomiting
- Headache
- Flush (vasodilatation)
- Hypertension
- Hypotension
- Tachycardia
- Dyspnea/respiratory adverse events
o Other adverse event(s)
(5) Serious Adverse event(s)
3. Efficacy endpoints:
(1) Overall success rate
* Defined as a composite of five criteria
o Survival for 7 days after completion of the observational treatment
o Fever resolved during neutropenic period
* Defined as a tympanic temperature < 38°C for at least 48 hours
o Baseline fungal infection cured (if present)
* Defined as (i) resolution of all attributable clinical symptoms and signs of
fungal infection during the observational period, (ii) negative microbiological
result at the EOT, if available
o No breakthrough fungal infections (proved, probable and possible) during
administration of the observational drug or within 7 days after the
completion of observational treatment
o Absence of premature discontinuation of the observational drug because of
toxicity or lack of efficacy
(2) Overall survival rate

Inclution Criteria

(1) Female or male with no age limit
(2) Patient for whom Lipo-AB® is medically recommended due to following conditions:
o Absolute neutrophil count (ANC) <500/mm3 for at least 96 hours
o Received parenteral broad spectrum antibacterial therapy for at least 96 hours
o Fever of ≥ 38.0°C(tympanic temperature)
(3) Subject or his/her legally acceptable representative is willing and able to provide a written informed consent

Exclusion Criteria

(1) Pregnant female, with the exception of those for whom the possible benefits to be derived outweigh the potential risks involved
(2) Use of other investigational product 2 weeks before the initiation of Lipo-AB® treatment which is considered not suitable for this study by investigator
(3) Use of any parenteral antifungals for current infection which is not considered treatment failure (either intolerance to the drug or lack of response)
(4) Any condition which is considered not suitable for liposomal amphotericin B therapy by investigator

Withdrawal criteria:
(1) Subject consent withdrawal
(2) Lost to follow-up
(3) Subject with insufficient response to Lipo-AB® who needs to combine with or switch to other antifungal agent

The Estimated Number of Participants

  • Taiwan

    54 participants

  • Global

    0 participants

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