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

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ClinicalTrials.gov Identifier: NCT04225195
Recruitment Status : Not yet recruiting
First Posted : January 13, 2020
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Invasive Candidiasis Invasive Aspergillosis Drug: Amphotericin B cholesteryl sulfate complex for injection(ABCD) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open, Multicenter Clinical Study to Evaluate the Safety, Efficacy, and Population Pharmacokinetics of ABCD for Invasive Candidiasis and Invasive Aspergillosis
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : June 2022


Arm Intervention/treatment
Experimental: Amphotericin B cholesteryl sulfate complex for injection(ABCD)

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.

Drug: Amphotericin B cholesteryl sulfate complex for injection(ABCD)

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.

Other Name: ABCD




Primary Outcome Measures :
  1. Number of patients who discontinued treatment due to study drug-related adverse events or abnormal laboratory tests, Intent-to-Treat (ITT) analysis set [ Time Frame: 4-6 weeks ]
    Number of patients who discontinued treatment due to study drug-related adverse events or abnormal laboratory tests, ITT analysis set

  2. Overall response success rate at the end of ABCD treatment, modified ITT (mITT) analysis set [ Time Frame: 4-6 weeks ]
    Overall response success rate at the end of ABCD treatment, m ITT analysis set

  3. 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 ]
    Proportion of patients who discontinued treatment due to study drug-related adverse events or abnormal laboratory tests, ITT analysis set


Secondary Outcome Measures :
  1. Overall response success rate at the end of ABCD treatment, Per Protocol Set(PPS) analysis set. [ Time Frame: 4-6 weeks ]
    Overall response success rate at the end of ABCD treatment, PPS analysis set.

  2. The proportion of patients with microbiologically effective outcome at the end of treatment, micro-mITT analysis set [ Time Frame: 4-6 weeks ]
    The proportion of patients with microbiologically effective outcome at the end of treatment, micro-mITT analysis set

  3. 30-d all-cause mortality rate after starting treatment; mITT analysis set [ Time Frame: 30 days after starting treatment ]
    30-d all-cause mortality rate after starting treatment; mITT analysis set



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with confirmed invasive candidiasis or confirmed/probable/possible invasive aspergillosis;
  2. Agree to use contraceptive measures from the date of signing the informed consent to 6 weeks after the end of the last medication;
  3. 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.
  4. Signed Informed Consent Form.

Exclusion Criteria:

  1. Allergic to ABCD or azole antifungal drugs;
  2. 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;
  3. 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;
  4. Patients with Candida endocarditis, osteomyelitis, arthritis, endophthalmitis, abscess of liver and/or spleen, suppurative thrombophlebitis, or central nervous system infection;
  5. Patients with a history of drug abuse or drug dependence;
  6. Chronic pulmonary aspergillosis (duration ≥ 3 months), aspergilloma or allergic bronchopulmonary aspergillosis;
  7. Patients are known to have mixed invasive Candida or Aspergillus infections and/or ABCD is known to be ineffective;
  8. Patients with abnormal liver function;
  9. Patients with reduced renal function who require or are currently undergoing hemodialysis or peritoneal dialysis;
  10. Hypokalemia, which cannot be corrected before trial treatment;
  11. Expected survival time is less than 2 months;
  12. Patients with cardiac function of New York Heart Association(NYHA)class III/IV;
  13. Positive for HIV antibody;
  14. Pregnant or lactating women;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04225195


Contacts
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Contact: xiugao yang 86-021-60677906 yangxiugao@mail.ecspc.com

Sponsors and Collaborators
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Investigators
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Principal Investigator: mingui wang Huashan Hospital affiliated to Fudan University ,Shanghai, China
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Responsible Party: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT04225195    
Other Study ID Numbers: CSPC/ LXMSB201901/PRO-III/A
First Posted: January 13, 2020    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Candidiasis
Aspergillosis
Candidiasis, Invasive
Mycoses
Bacterial Infections and Mycoses
Infections
Invasive Fungal Infections
Amphotericin B
Liposomal amphotericin B
Cholesteryl sulfate
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Anti-Bacterial Agents
Antifungal Agents
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents