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

CSPC Pharmaceutical Group

Status and phase: Completed; Phase 3

Conditions: Invasive Mold Disease

Treatments: Drug: ABCD

Study type: Interventional

Funder types: Industry

Identifiers

NCT07239765

LXMSB201902/PRO-III

Details and patient eligibility

About

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.

Enrollment: 67 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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67 participants in 1 patient group

ABCD

Experimental group

Description:

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

Treatment:

Drug: ABCD