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NCT Number: NCT03511820

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

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.

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Key information

Conditions

Neutropenia, Febrile Agranulocytosis Cytopenia Febrile Neutropenia Hematologic Diseases Hemic and Lymphatic Diseases Leukocyte Disorders Leukopenia Neutropenia

Sex eligibility

All sexes

Study type

Observational

Primary location

Changhua Christian Hospital, Changhua, Taiwan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Lipo-AB® (amphotericin B) liposome

Drug
  • Name: Lipo-AB® (amphotericin B) liposome for injection
  • Dosage form: Lyophilized powder 50 mg/vial
  • Dose: Based on approved package insert and physician's discretion Recommended initial dose: 3 mg/kg/day
  • Dosing schedule:

All patients will receive Lipo-AB® based on the approved package insert and physician's clinical decision.

Primary outcomes

  1. Incidence rate of nephrotoxicity

    Time frame: through Observation period (up to 44 days)

    • 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.

Secondary outcomes

  1. Categorization of the change in renal function

    Time frame: through Observation period (up to 44 days)

    • SCr < 1.5 x baseline SCr (BSC)
    • SCr ≥ 1.5 x BSC
    • SCr ≥ 2 x BSC
    • SCr ≥ 3 x BSC

  2. Change in laboratory parameters (1)

    Time frame: through Observation period (up to 44 days)

    hemoglobin (Hb in g/dL)

  3. Change in laboratory parameters (2)

    Time frame: through Observation period (up to 44 days)

    hematocrit (Hct in %)

  4. Change in laboratory parameters (3)

    Time frame: through Observation period (up to 44 days)

    red blood cell (RBC in 10^6/uL)

  5. Change in laboratory parameters (4)

    Time frame: through Observation period (up to 44 days)

    white blood cell (WBC in 10^3/uL)

  6. Change in laboratory parameters (5)

    Time frame: through Observation period (up to 44 days)

    ANC (absolute neutrophil count in mm^3)

  7. Change in laboratory parameters (6)

    Time frame: through Observation period (up to 44 days)

    platelet count in 10^3/uL

  8. Change in laboratory parameters (7)

    Time frame: through Observation period (up to 44 days)

    alanine aminotransferase (ALT in U/L)

  9. Change in laboratory parameters (8)

    Time frame: through Observation period (up to 44 days)

    aspartate aminotransferase (AST in U/L)

  10. Change in laboratory parameters (9)

    Time frame: through Observation period (up to 44 days)

    total bilirubin (TB in mg/dL)

  11. Change in laboratory parameters (10)

    Time frame: through Observation period (up to 44 days)

    BUN in mg/dL

  12. Change in laboratory parameters (11)

    Time frame: through Observation period (up to 44 days)

    serum creatinine (SCr in mg/dL)

  13. Change in laboratory parameters (12)

    Time frame: through Observation period (up to 44 days)

    glucose (mg/dL)

  14. Change in laboratory parameters (13)

    Time frame: through Observation period (up to 44 days)

    Na (mmol/L)

  15. Change in laboratory parameters (14)

    Time frame: through Observation period (up to 44 days)

    K (mmol/L)

  16. Change in laboratory parameters (15)

    Time frame: through Observation period (up to 44 days)

    Mg (mg/dL)

  17. Change in laboratory parameters (16)

    Time frame: through Observation period (up to 44 days)

    Ca (mg/dL)

  18. Change in laboratory parameters (17)

    Time frame: through Observation period (up to 44 days)

    Urine protein (mg/dL)

  19. Change in vital signs (1)

    Time frame: through Observation period (up to 44 days)

    systolic/diastolic blood pressure (SBP/ DBP in mmHg)

  20. Change in vital signs (2)

    Time frame: through Observation period (up to 44 days)

    pulse rate (PR in bpm)

  21. Change in vital signs (3)

    Time frame: through Observation period (up to 44 days)

    tympanic temperature (TT in °C)

  22. Adverse event(s)

    Time frame: through Observation period (up to 44 days)

    Hypokalemia, Hypomagnesemia, Hypocalcemia, Hypernatremia, Hyponatremia, Infusion-related reaction(s) (IRR), Other adverse event(s).

  23. Overall success rate

    Time frame: through Observation period (up to 44 days)

    Defined as a composite of five criteria:

    • Survival for 7 days after completion of the observational treatment
    • Fever resolved during neutropenic period: defined as a tympanic temperature < 38°C for at least 48 hours
    • 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 (end of treatment), if available
    • No breakthrough fungal infections (proved, probable and possible) during administration of the observational drug or within 7 days after the completion of observational treatment
    • Absence of premature discontinuation of the observational drug because of toxicity or lack of efficacy

  24. Overall survival rate

    Time frame: through Observation period (up to 44 days)

Sponsors and collaborators

Lead sponsor

TTY Biopharm

Industry

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 30, 2018
Registry last updated
Apr 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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