NCT07239765

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2021

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 9, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2024

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2024

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 20, 2025

Completed
Last Updated

November 20, 2025

Status Verified

September 1, 2025

Enrollment Period

2.8 years

First QC Date

November 16, 2025

Last Update Submit

November 16, 2025

Conditions

Invasive Mold Disease

Outcome Measures

Primary Outcomes (1)

  • Incidence and severity of adverse events (AEs)

    Up to 14 weeks

Secondary Outcomes (6)

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

    Up to 12 weeks

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

    Up to 12 weeks

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

    Up to 12 weeks

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

    Up to 12 weeks

  • The proportion of patients achieving the clinical response of CR or PR

    Up to 12 weeks

  • +1 more secondary outcomes

Study Arms (1)

ABCD

EXPERIMENTAL

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

Drug: ABCD

Interventions

ABCDDRUG

intravenous infusion

ABCD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital Of Guangzhou Medical University

Guangzhou, China

Location

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Multicenter, Open-label, Single-arm Study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2025

First Posted

November 20, 2025

Study Start

July 9, 2021

Primary Completion

April 8, 2024

Study Completion

April 29, 2024

Last Updated

November 20, 2025

Record last verified: 2025-09

Locations

CN(1)