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

NCT03511820 | Completed

• 1 other identifier: TTYLA1201
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 9

Brief 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. 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. 1.Primary objective:
2. 2.To evaluate the nephrotoxicity of Lipo-AB® (amphotericin B) treatment in neutropenic patients with persistent fever in Taiwan clinical practice.
3. 3.Secondary objectives:

Conditions

Neutropenia, Febrile

Keywords

Amphotericin B; liposome; post marketing surveillance

Outcome Measures

Primary Outcomes (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.

  through Observation period (up to 44 days)

Secondary Outcomes (24)

• Categorization of the change in renal function

  through Observation period (up to 44 days)

• Change in laboratory parameters (1)

  through Observation period (up to 44 days)

• Change in laboratory parameters (2)

  through Observation period (up to 44 days)

• Change in laboratory parameters (3)

  through Observation period (up to 44 days)

• Change in laboratory parameters (4)

  through Observation period (up to 44 days)

Interventions

Lipo-AB® (amphotericin B) liposome DRUG

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TTY Biopharm: lead

Study Sites (9)

Changhua Christian Hospital

Changhua, 500, Taiwan

Location

Kaohsiung Veterans General Hospital

Kaohsiung City, 81362, Taiwan

Location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

Location

Keelung Chang Gung Memorial Hospital

Keelung, 204, Taiwan

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11212, Taiwan

Location

Tri-Service General Hospital

Taipei, 114, Taiwan

Location

Taipei Mucinipal Wanfang Hospital

Taipei, 116, Taiwan

Location

Chang Guang Memorial Hospital at LinKou

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Febrile Neutropenia

Interventions

Amphotericin B; Liposomes

Condition Hierarchy (Ancestors)

Neutropenia; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals; Membranes, Artificial; Biomedical and Dental Materials; Drug Carriers; Dosage Forms; Pharmaceutical Preparations; Manufactured Materials; Technology, Industry, and Agriculture; Biomimetic Materials

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2018
• First Posted: April 30, 2018
• Study Start: May 24, 2016
• Primary Completion: January 15, 2018
• Study Completion: January 15, 2018
• Last Updated: April 30, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (9)