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Neutropenia, FebrileNCT03511820

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

An observational study of Neutropenia, Febrile, run by TTY Biopharm at 9 sites in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Neutropenia, Febrile
What is being tested?
Lipo-AB® (amphotericin B) liposome
Type of treatment
Injection or infusion
How many people
54 participants
Where
9 sitesTaiwan
Study dates
24 May 2016to 15 Jan 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Neutropenic patients with persistent fever who are recommended to receive systemic antifungal therapy based on physician's decision will be invited to participate in this study.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Taiwan9 sites

  • Changhua Christian Hospital

    Changhua, 500

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 81362

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 833

  • Keelung Chang Gung Memorial Hospital

    Keelung, 204

  • China Medical University Hospital

    Taichung, 40447

  • Taipei Veterans General Hospital

    Taipei, 11212

  • Tri-Service General Hospital

    Taipei, 114

  • Taipei Mucinipal Wanfang Hospital

    Taipei, 116

  • Chang Guang Memorial Hospital at LinKou

    Taoyuan, 333

Other trials in Taiwan

About this study

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:
Read more
  • To evaluate the nephrotoxicity of Lipo-AB® (amphotericin B) treatment in neutropenic patients with persistent fever in Taiwan clinical practice.
  1. 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.
Being tested
Lipo-AB® (amphotericin B) liposome
Keywords
Amphotericin B, liposome, post marketing surveillance
Medical subject headings
Febrile Neutropenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lipo-AB® (amphotericin B) liposomeDrug

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

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: through Observation period (up to 44 days)

Secondary outcomes (24)

  1. Categorization of the change in renal function

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

    Measured: through Observation period (up to 44 days)

  2. Change in laboratory parameters (1)

    hemoglobin (Hb in g/dL)

    Measured: through Observation period (up to 44 days)

  3. Change in laboratory parameters (2)

    hematocrit (Hct in %)

    Measured: through Observation period (up to 44 days)

  4. Change in laboratory parameters (3)

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

    Measured: through Observation period (up to 44 days)

  5. Change in laboratory parameters (4)

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

    Measured: through Observation period (up to 44 days)

  6. Change in laboratory parameters (5)

    ANC (absolute neutrophil count in mm^3)

    Measured: through Observation period (up to 44 days)

  7. Change in laboratory parameters (6)

    platelet count in 10^3/uL

    Measured: through Observation period (up to 44 days)

  8. Change in laboratory parameters (7)

    alanine aminotransferase (ALT in U/L)

    Measured: through Observation period (up to 44 days)

  9. Change in laboratory parameters (8)

    aspartate aminotransferase (AST in U/L)

    Measured: through Observation period (up to 44 days)

  10. Change in laboratory parameters (9)

    total bilirubin (TB in mg/dL)

    Measured: through Observation period (up to 44 days)

  11. Change in laboratory parameters (10)

    BUN in mg/dL

    Measured: through Observation period (up to 44 days)

  12. Change in laboratory parameters (11)

    serum creatinine (SCr in mg/dL)

    Measured: through Observation period (up to 44 days)

  13. Change in laboratory parameters (12)

    glucose (mg/dL)

    Measured: through Observation period (up to 44 days)

  14. Change in laboratory parameters (13)

    Na (mmol/L)

    Measured: through Observation period (up to 44 days)

  15. Change in laboratory parameters (14)

    K (mmol/L)

    Measured: through Observation period (up to 44 days)

  16. Change in laboratory parameters (15)

    Mg (mg/dL)

    Measured: through Observation period (up to 44 days)

  17. Change in laboratory parameters (16)

    Ca (mg/dL)

    Measured: through Observation period (up to 44 days)

  18. Change in laboratory parameters (17)

    Urine protein (mg/dL)

    Measured: through Observation period (up to 44 days)

  19. Change in vital signs (1)

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

    Measured: through Observation period (up to 44 days)

  20. Change in vital signs (2)

    pulse rate (PR in bpm)

    Measured: through Observation period (up to 44 days)

  21. Change in vital signs (3)

    tympanic temperature (TT in °C)

    Measured: through Observation period (up to 44 days)

  22. Adverse event(s)

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

    Measured: through Observation period (up to 44 days)

  23. Overall success rate

    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

    Measured: through Observation period (up to 44 days)

  24. Overall survival rate

    Measured: through Observation period (up to 44 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2018
  2. Study start24 May 2016
  3. Primary completion15 Jan 2018
  4. Study completion15 Jan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03511820
Sponsor's protocol ID
TTYLA1201
Status last verified
Apr 2018
First submitted
1 Apr 2018
Last updated
30 Apr 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Neutropenia, Febrile, run by TTY Biopharm at 9 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence rate of nephrotoxicity (time frame: through Observation period (up to 44 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03511820.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2018.

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