A Study to Evaluate the Safety, Efficacy, and PPK of ABCD... | NCT07239765

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

NCT07239765

Sponsor

CSPC Ouyi Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Nov 20, 2025Actual

Enrollment

67Actual

Phase

Phase 3

Conditions

Invasive Mold Disease

Interventions

ABCD

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 9, 2021Actual

Primary Completion Date

Apr 8, 2024Actual

Completion Date

Apr 29, 2024Actual

First Submitted Date

Nov 16, 2025

First Submission Date that Met QC Criteria

Nov 16, 2025

First Posted Date

Nov 20, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 16, 2025

Last Update Posted Date

Nov 20, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

67Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ABCD	Experimental	Patients received ABCD at a dose of 3-4 mg/kg for 2-12weeks	Drug: ABCD

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ABCD	Drug	intravenous infusion	ABCD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence and severity of adverse events (AEs)		Up to 14 weeks

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The First Affiliated Hospital Of Guangzhou Medical University		Guangzhou			China