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

NCT ID: NCT03511820

Last Updated: 2018-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-24

Study Completion Date

2018-01-15

Brief Summary

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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.

Detailed Description

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Conditions

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Neutropenia, Febrile

Keywords

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Amphotericin B liposome post marketing surveillance

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Lipo-AB® (amphotericin B) liposome

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Female or male with no age limit
2. 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)
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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TTY Biopharm

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Changhua Christian Hospital

Changhua, , Taiwan

Site Status

Kaohsiung Veterans General Hospital

Kaohsiung City, , Taiwan

Site Status

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Site Status

Keelung Chang Gung Memorial Hospital

Keelung, , Taiwan

Site Status

China Medical University Hospital

Taichung, , Taiwan

Site Status

Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status

Tri-Service General Hospital

Taipei, , Taiwan

Site Status

Taipei Mucinipal Wanfang Hospital

Taipei, , Taiwan

Site Status

Chang Guang Memorial Hospital at LinKou

Taoyuan District, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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TTYLA1201

Identifier Type: -

Identifier Source: org_study_id