A Study to Evaluate the Safety, Efficacy, and PPK of ABCD in Patients With IMD

NCT ID: NCT07239765

Last Updated: 2025-11-20

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

Clinical Phase

PHASE3

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-09

Study Completion Date

2024-04-29

Brief Summary

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Amphotericin B Cholesteryl Sulfate Complex (ABCD) is a generic drug of amphotericin B colloidal dispersion. This study aimed to explore the safety and efficacy of ABCD in patients with invasive mold disease.

Detailed Description

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Conditions

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Invasive Mold Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Multicenter, Open-label, Single-arm Study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ABCD

Patients received ABCD at a dose of 3-4 mg/kg for 2-12weeks

Group Type EXPERIMENTAL

ABCD

Intervention Type DRUG

intravenous infusion

Interventions

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ABCD

intravenous infusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ≥18 years of age;
* Participant had a diagnosis of proven/probable invasive mold disease (IMD) as determined according to European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC-MSG) criteria (2019 version) or proven/probable talaromycosis as determined according to diagnostic criteria for endemic mycosis.

Exclusion Criteria

* Allergy to amphotericin B or cholesteryl sulfate complex;
* Mycoses only involved skin above fascia;
* Expected survival less than 2 months;
* Pregnant or breast-feeding;
* Non-negative result on HIV antibody
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CSPC Ouyi Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The First Affiliated Hospital Of Guangzhou Medical University

Guangzhou, , China

Site Status

Countries

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China

Other Identifiers

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LXMSB201902/PRO-III

Identifier Type: -

Identifier Source: org_study_id

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