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OpenTrials
Completed

NCT Number: NCT07239765

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

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.

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Key information

Conditions

Invasive Mold Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The First Affiliated Hospital Of Guangzhou Medical University

Guangzhou, China

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

ABCD

Drug

intravenous infusion

Primary outcomes

  1. Incidence and severity of adverse events (AEs)

    Time frame: Up to 14 weeks

Secondary outcomes

  1. The percentages of the patients who completed the 2 week ABCD therapeutic regimen

    Time frame: Up to 12 weeks

  2. The percentages of the patients who completed the 4 week ABCD therapeutic regimen

    Time frame: Up to 12 weeks

  3. The percentages of the patients who completed the 6 week ABCD therapeutic regimen

    Time frame: Up to 12 weeks

  4. The proportion of patients achieving the clinical response of complete remission (CR), partial remission (PR) or stable disease (SD)

    Time frame: Up to 12 weeks

  5. The proportion of patients achieving the clinical response of CR or PR

    Time frame: Up to 12 weeks

  6. The proportion of patients with a microbiological response of eradication or presumed eradication

    Time frame: Up to 12 weeks

Sponsors and collaborators

Lead sponsor

CSPC Ouyi Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

An Open-label Study to Evaluate the Safety, Efficacy, and Population Pharmacokinetic Characteristics of Amphotericin B Cholesteryl Sulfate Complex Injection in Patients With Invasive Mold Disease

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Nov 20, 2025
Registry last updated
Nov 20, 2025

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.