A Study to Evaluate the Safety, Efficacy, and PPK of ABCD in Patients With IMD
Not Applicable
Completed
- Conditions
- Invasive Mold Disease
- Interventions
- Drug: ABCD
- Registration Number
- NCT07239765
- Lead Sponsor
- CSPC Ouyi Pharmaceutical Co., Ltd.
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 67
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ABCD ABCD Patients received ABCD at a dose of 3-4 mg/kg for 2-12weeks
- Primary Outcome Measures
Name Time Method Incidence and severity of adverse events (AEs) Up to 14 weeks
- Secondary Outcome Measures
Name Time Method 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 The proportion of patients with a microbiological response of eradication or presumed eradication Up to 12 weeks
Trial Locations
- Locations (1)
The First Affiliated Hospital Of Guangzhou Medical University
🇨🇳Guangzhou, China
The First Affiliated Hospital Of Guangzhou Medical University🇨🇳Guangzhou, China