Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-25 @ 7:10 PM
Study NCT ID:
NCT05707832
Status:
COMPLETED
Last Update Posted:
2025-04-09
First Post:
2022-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of ABCD for Injection in Subjects With Invasive Candidiasis and Invasive Aspergillus
Sponsor:
CSPC Ouyi Pharmaceutical Co., Ltd.
Organization:
Study Overview
Official Title:
An Open Clinical Trial to Evaluate the Safety, Efficacy and Population Pharmacokinetics of Amphotericin B Cholesteryl Sulfate Complex for Injection in Subjects With Invasive Candidiasis and Invasive Aspergillus
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multi-center, open-label, non-controlled, single-arm clinical trial to evaluate the safety, efficacy and population pharmacokinetics of Amphotericin B cholesteryl Sulfate Complex for Injection domestic formulations (ABCD) in the treatment of confirmed invasive candidiasis (IC) and confirmed/clinically diagnosed invasive aspergillus (IA) disease.
Detailed Description:
The study includes a screening period (day -14 to day -1), a baseline period (day 1), a treatment period, and a follow-up period (14±3 days after the end of administration). Eligible subjects will receive intravenous ABCD infusion. A test dose of 2 mg/10 mL will be given at baseline, followed by titration after the evaluation of the subjects' symptoms, signs and tolerance by investigator, until reaching the recommended dose of 3.0-4.0 mg/kg once a day for treatment. IC subjects will receive ABCD intravenous therapy for a minimum of 2 weeks, and a maximum of 14 days after the first negative turn of candida culture in blood or other normal sterile sites and the symptoms and signs of infection disappear/improve significantly, up to a maximum of 6 weeks. IA subjects will be treated with ABCD for at least 2 weeks and up to 6 weeks. After the end of intravenous therapy, according to the individual condition of the subjects, pathogens, drug sensitivity test, and the therapeutic effect of ABCD, the investigator will make a comprehensive judgment on whether to give sequential therapy drugs, but the total course of treatment shall not exceed the duration specified in the above scheme (the number of days of ABCD intravenous therapy plus the number of days of sequential therapy shall not exceed 6 weeks). The study will end when the last subject completed the follow-up period.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: