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Amphotericin B Cholesteryl Sulfate Complex for Injection(ABCD) in the Treatment of Invasive Candidiasis and Invasive Aspergillosis

Primary Purpose

Invasive Candidiasis, Invasive Aspergillosis

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Amphotericin B cholesteryl sulfate complex for injection(ABCD)

About this trial

This is an interventional treatment trial for Invasive Candidiasis

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with confirmed invasive candidiasis or confirmed/probable/possible invasive aspergillosis;
Agree to use contraceptive measures from the date of signing the informed consent to 6 weeks after the end of the last medication;
Female subjects must meet one of the following conditions: surgical sterilization;menopause for at least 1 year;a negative result of serum/urine pregnancy test before enrollment.
Signed Informed Consent Form.

Exclusion Criteria:

Allergic to ABCD or azole antifungal drugs；
For IC patients, administration of more than 48 hours of systemic antifungal treatment within 96 hours before enrollment; or 1 dose of amphotericin B in 7 days;
For IA patients, administration of more than 96 hours of systemic antifungal therapy for this infection before enrollment, or 1 dose of amphotericin B in 7 days;
Patients with Candida endocarditis, osteomyelitis, arthritis, endophthalmitis, abscess of liver and/or spleen, suppurative thrombophlebitis, or central nervous system infection;
Patients with a history of drug abuse or drug dependence;
Chronic pulmonary aspergillosis (duration ≥ 3 months), aspergilloma or allergic bronchopulmonary aspergillosis;
Patients are known to have mixed invasive Candida or Aspergillus infections and/or ABCD is known to be ineffective;
Patients with abnormal liver function;
Patients with reduced renal function who require or are currently undergoing hemodialysis or peritoneal dialysis;
Hypokalemia, which cannot be corrected before trial treatment;
Expected survival time is less than 2 months;
Patients with cardiac function of New York Heart Association（NYHA）class III/IV;
Positive for HIV antibody;
Pregnant or lactating women;

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Amphotericin B cholesteryl sulfate complex for injection(ABCD)

Arm Description

Patients with invasive candidiasis (IC) will only receive intravenous treatment with ABCD. ABCD will be administered once a day at a dose of 3-4 mg/kg. Patients with invasive aspergillosis (IA) will be treated with ABCD for 4 weeks first, followed by oral administration of voriconazole. ABCD dosing regimen will be the same as that for IC patients.

Outcomes

Primary Outcome Measures

Number of patients who discontinued treatment due to study drug-related adverse events or abnormal laboratory tests, Intent-to-Treat (ITT) analysis set

Number of patients who discontinued treatment due to study drug-related adverse events or abnormal laboratory tests, ITT analysis set

Overall response success rate at the end of ABCD treatment, modified ITT (mITT) analysis set

Overall response success rate at the end of ABCD treatment, m ITT analysis set

Proportion of patients who discontinued treatment due to study drug-related adverse events or abnormal laboratory tests, ITT analysis set

Secondary Outcome Measures

Overall response success rate at the end of ABCD treatment, Per Protocol Set(PPS) analysis set.

Overall response success rate at the end of ABCD treatment, PPS analysis set.

The proportion of patients with microbiologically effective outcome at the end of treatment, micro-mITT analysis set

30-d all-cause mortality rate after starting treatment; mITT analysis set

Full Information

NCT ID

NCT04225195

First Posted

January 3, 2020

Last Updated

January 8, 2020

Sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04225195

Brief Title

Amphotericin B Cholesteryl Sulfate Complex for Injection(ABCD) in the Treatment of Invasive Candidiasis and Invasive Aspergillosis

Official Title

An Open, Multicenter Clinical Study to Evaluate the Safety, Efficacy, and Population Pharmacokinetics of ABCD for Invasive Candidiasis and Invasive Aspergillosis

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Unknown status

Study Start Date

January 2020 (Anticipated)

Primary Completion Date

April 2022 (Anticipated)

Study Completion Date

June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This is an open, multicenter clinical trial of ABCD for invasive candidiasis and invasive aspergillosis.

Detailed Description

This study will evaluate the safety, efficacy and population pharmacokinetic characteristics of ABCD in the treatment of invasive candidiasis and invasive aspergillosis. About 60 patients with confirmed invasive candidiasis or confirmed/probable/possible invasive aspergillosis will be enrolled.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Invasive Candidiasis, Invasive Aspergillosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Amphotericin B cholesteryl sulfate complex for injection(ABCD)

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Amphotericin B cholesteryl sulfate complex for injection(ABCD)

Other Intervention Name(s)

ABCD

Intervention Description

IC patients will only receive intravenous treatment with ABCD, with the longest course of treatment up to 42 days. ABCD will be administered once a day at a dose of 3-4 mg/kg. Visit plan: screening period (D-4 to D-1), baseline period (D1), treatment period and follow-up period (14±3days after the end of the last dose of ABCD). IA patients will be treated with ABCD for 4 weeks first, followed by oral administration of voriconazole. The total course of treatment should be at least 6 to 12 weeks. ABCD dosing regimen will be the same as that for IC patients. Visiting plan: screening period (D-4to D-1), baseline period (D1), treatment period and follow-up period.

Primary Outcome Measure Information:

Title

Number of patients who discontinued treatment due to study drug-related adverse events or abnormal laboratory tests, Intent-to-Treat (ITT) analysis set

Description

Number of patients who discontinued treatment due to study drug-related adverse events or abnormal laboratory tests, ITT analysis set

Time Frame

4-6 weeks

Title

Overall response success rate at the end of ABCD treatment, modified ITT (mITT) analysis set

Description

Overall response success rate at the end of ABCD treatment, m ITT analysis set

Time Frame

4-6 weeks

Title

Proportion of patients who discontinued treatment due to study drug-related adverse events or abnormal laboratory tests, ITT analysis set

Description

Proportion of patients who discontinued treatment due to study drug-related adverse events or abnormal laboratory tests, ITT analysis set

Time Frame

4-6 weeks

Secondary Outcome Measure Information:

Title

Overall response success rate at the end of ABCD treatment, Per Protocol Set(PPS) analysis set.

Description

Overall response success rate at the end of ABCD treatment, PPS analysis set.

Time Frame

4-6 weeks

Title

The proportion of patients with microbiologically effective outcome at the end of treatment, micro-mITT analysis set

Description

The proportion of patients with microbiologically effective outcome at the end of treatment, micro-mITT analysis set

Time Frame

4-6 weeks

Title

30-d all-cause mortality rate after starting treatment; mITT analysis set

Description

30-d all-cause mortality rate after starting treatment; mITT analysis set

Time Frame

30 days after starting treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with confirmed invasive candidiasis or confirmed/probable/possible invasive aspergillosis; Agree to use contraceptive measures from the date of signing the informed consent to 6 weeks after the end of the last medication; Female subjects must meet one of the following conditions: surgical sterilization;menopause for at least 1 year;a negative result of serum/urine pregnancy test before enrollment. Signed Informed Consent Form. Exclusion Criteria: Allergic to ABCD or azole antifungal drugs； For IC patients, administration of more than 48 hours of systemic antifungal treatment within 96 hours before enrollment; or 1 dose of amphotericin B in 7 days; For IA patients, administration of more than 96 hours of systemic antifungal therapy for this infection before enrollment, or 1 dose of amphotericin B in 7 days; Patients with Candida endocarditis, osteomyelitis, arthritis, endophthalmitis, abscess of liver and/or spleen, suppurative thrombophlebitis, or central nervous system infection; Patients with a history of drug abuse or drug dependence; Chronic pulmonary aspergillosis (duration ≥ 3 months), aspergilloma or allergic bronchopulmonary aspergillosis; Patients are known to have mixed invasive Candida or Aspergillus infections and/or ABCD is known to be ineffective; Patients with abnormal liver function; Patients with reduced renal function who require or are currently undergoing hemodialysis or peritoneal dialysis; Hypokalemia, which cannot be corrected before trial treatment; Expected survival time is less than 2 months; Patients with cardiac function of New York Heart Association（NYHA）class III/IV; Positive for HIV antibody; Pregnant or lactating women;

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

xiugao yang

Phone

86-021-60677906

yangxiugao@mail.ecspc.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

mingui wang

Organizational Affiliation

Huashan Hospital affiliated to Fudan University ,Shanghai, China

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Amphotericin B Cholesteryl Sulfate Complex for Injection(ABCD) in the Treatment of Invasive Candidiasis and Invasive Aspergillosis

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