Neutropenia and FeverPhase 3NCT05108545
A Study of Amphotericin B Liposome for Injection in Patients With Persistent Neutropenia and Fever
A Phase 3 study testing Amphotericin B liposomes in people with Neutropenia and Fever, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..
Trial summary
This is a multicenter, open-label, single-arm, phase III study to evaluate the safety and efficacy of Amphotericin B liposomes in patients with persistent neutropenia and fever. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neutropenia and Fever
- What is being tested?
- Amphotericin B liposomes
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2021to 15 Jan 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 ~ 75 years (inclusive), no gender limitation.
- Patients with neutrophilic deficiency after solid tumor chemotherapy, hematological tumor chemotherapy, hematopoietic stem cell transplantation, etc. (absolute neutrophil count (ANC) in peripheral blood <500 /mm^3 (0.5×10^9 /L) for at least 72 hours at screening).
- Persistent or recurrent fever (oral temperature ≥38℃ or axillary temperature ≥37.7℃ within 24 hours prior to randomization) after at least 72 hours on broad-spectrum antibiotics, and considering fever to be associated with suspected fungal infection.
- Female patients must meet one of the following conditions:
- Menopausal patients, menopause at least 1 year;
- Patients of childbearing age: Negative for blood/urine pregnancy test before enrollment; agree to take a guaranteed, effective contraception during the study and within 4 weeks after the study.
- Male patients and their partners must use effective contraception throughout the study period and up to 4 weeks after leaving the study.
- Patients fully understand and voluntarily participate in this study and sign informed consent.
Who cannot join
- History of allergy to liposomes or amphotericin B.
- Received systemic treatment of amphotericin B or amphotericin B-containing formulation within 10 days prior to enrollment.
- Liposome used within 1 month before the signing informed consent.
- Confirmed or clinically diagnosed invasive fungal infection or known uncontrolled bacteremia or sepsis at screening.
- Eastern Cooperative Oncology Group (ECOG) performance status ≥3;
- Abnormal liver function, aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≥5 × the upper limit of normal (ULN), or ALT/AST ≥3 × ULN with total bilirubin ≥1.5 × ULN, or total bilirubin ≥3 × ULN.
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- Serum creatinine > 2 × ULN.
- Serum potassium concentration ≤3.0 mmol/L prior to the first administration, or serum potassium concentration ≤the lower limit of normal value (LLN) in patients undergoing digitalization.
- 12-lead ECG presenting II or III degree atrioventricular block, long QT syndrome or corrected QT interval>480 ms in the absence of a pacemaker.
- Cardiac function grade III/IV (NYHA).
- Tachyarrhythmia requiring intervention and a history of high-risk coronary heart disease such as unstable angina and acute coronary syndrome.
- Human immunodeficiency virus (HIV) antibody or treponema pallidum specific antibody (TPHA) positive; active tuberculosis on CT of chest (to be determined by investigator).
- Pregnant or lactating female.
- A history of drug abuse (non-medical use of narcotic drugs or psychotropic substances) or drug dependence (narcotics, stimulants and psychotropic substances, etc.) within 2 years.
- Plan to use prohibited drugs during the study period.
- Enrolled in any other clinical trials of drugs or medical devices within 3 months prior to screening.
- Life expectancy < 2 months;
- Not suitable for this study as decided by the investigator due to other reasons
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multicenter, Open-label, Phase Ⅲ Study to Evaluate the Efficacy and Safety of Amphotericin B Liposome for Injection in Patients With Persistent Febrile Neutropenia
This is a multicenter, open-label, single-arm, phase III study to evaluate the safety and efficacy of Amphotericin B liposomes in patients with persistent neutropenia and fever.
Read the detailed description
This is a multicenter, open-label, single-arm, phase III study to evaluate the safety and efficacy of Amphotericin B liposomes in patients with persistent neutropenia and fever. About 93 patients will be recruited in this study. The patients will receive Amphotericin B liposomes intravenous infusion at a dose of 3 mg/kg over 2 hours once daily (qd) for a maximum of 12 weeks.
- Conditions
- Neutropenia and Fever
- Being tested
- Amphotericin B liposomes
- Medical subject headings
- Neutropenia, Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amphotericin B liposomesDrug
Amphotericin B liposomes for injection, 3 mg/kg, qd, IV
| Study group | Role | What they receive |
|---|---|---|
| Amphotericin B liposomes | Experimental | Patients with suspected fungal neutropenia and fever will receive amphotericin B liposome 3 mg/kg intravenously. Treatment will be continued until the ANC≥500 /mm^3 (0.5×10^9 /L) for more than 72 hrs in terms of patients without evidence of baseline fungal infection and breakthrough fungal infection; or treatment will be continued according to investigator's judgement with a duration ranging from 14 days to 12 weeks in terms of patients with evidence of baseline fungal infection and breakthrough fungal infection. Receives: Drug: Amphotericin B liposomes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall success rate
A successful outcome is defined as fulfilling all components of a prespecified 5-part composite endpoint.
Measured: From the initiation of the third dose to 7 days after the last dose
Secondary outcomes (8)
Percentage of patients without new fungal infections from the initiation of the first dose to 7 days after the last dose
Percentage of patients without new fungal infections
Measured: From the initiation of the third dose to 7 days after the last dose
Percentage of patients survived from the initiation of the first dose to 7 days after the last dose
Percentage of patients survived
Measured: From the initiation of the third dose to 7 days after the last dose
Percentage of patients without discontinuation of study drug due to side effects or lack of efficacy during the treatment period
Percentage of patients without discontinuation of study drug due to side effects or lack of efficacy
Measured: From the initiation of the third dose to 7 days after the last dose
Percentage of patients experienced fever reduction during neutropenia after initiation of treatment
Percentage of patients experienced fever reduction during neutropenia
Measured: From the initiation of the third dose to 7 days after the last dose
Percentage of patients with complete or partial remission of confirmed or clinically diagnosed IFD (baseline fungal infection) at the end of treatment
Percentage of patients with complete or partial remission of confirmed or clinically diagnosed Invasive fungal disease (baseline fungal infection)
Measured: From the initiation of the third dose to 7 days after the last dose
Adverse events
Adverse events
Measured: From the screening period to 14 days after the last dose
Pharmacokinetic profile of amphotericin B
Pharmacokinetic profile of amphotericin B, Such as "Peak Plasma Concentration (Cmax)"
Measured: Pre-dose and multiple timepoints up to 4 hours of the last dose
Pharmacokinetic profile of amphotericin B
Measured: Pre-dose and multiple timepoints up to 4 hours of the last dosePharmacokinetic profile of amphotericin B, Such as "Area under the plasma concentration versus time curve (AUC)"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start15 Dec 2021 (estimated)
- Primary completion31 Jul 2022 (estimated)
- Study completion15 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neutropenia and FeverStudies of the same condition, open and under way.
- More trials run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05108545
- Sponsor's protocol ID
- HC1507-CSP-001
- Status last verified
- Sep 2021
- First submitted
- 30 Sep 2021
- Last updated
- 5 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Phase Ⅲ Study to Evaluate the Efficacy and Safety of Amphotericin B Liposome for Injection in Patients With Persistent Febrile Neutropenia
- ClinicalTrials.gov ID
- NCT05108545
- Acronym / sponsor ID
- HC1507-CSP-001
- Conditions
- Neutropenia and Fever
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Dec 2021 (estimated)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 15 Jan 2023 (estimated)
- First posted
- 5 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, open-label, single-arm, phase III study to evaluate the safety and efficacy of Amphotericin B liposomes in patients with persistent neutropenia and fever.
Detailed description
This is a multicenter, open-label, single-arm, phase III study to evaluate the safety and efficacy of Amphotericin B liposomes in patients with persistent neutropenia and fever. About 93 patients will be recruited in this study. The patients will receive Amphotericin B liposomes intravenous infusion at a dose of 3 mg/kg over 2 hours once daily (qd) for a maximum of 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amphotericin B liposomes | Experimental | Drug: Amphotericin B liposomesPatients with suspected fungal neutropenia and fever will receive amphotericin B liposome 3 mg/kg intravenously. Treatment will be continued until the ANC≥500 /mm^3 (0.5×10^9 /L) for more than 72 hrs in terms of patients without evidence of baseline fungal infection and breakthrough fungal infection; or treatment will be continued according to investigator's judgement with a duration ranging from 14 days to 12 weeks in terms of patients with evidence of baseline fungal infection and breakthrough fungal infection. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged 18 ~ 75 years (inclusive), no gender limitation.
- Patients with neutrophilic deficiency after solid tumor chemotherapy, hematological tumor chemotherapy, hematopoietic stem cell transplantation, etc. (absolute neutrophil count (ANC) in peripheral blood <500 /mm^3 (0.5×10^9 /L) for at least 72 hours at screening).
- Persistent or recurrent fever (oral temperature ≥38℃ or axillary temperature ≥37.7℃ within 24 hours prior to randomization) after at least 72 hours on broad-spectrum antibiotics, and considering fever to be associated with suspected fungal infection.
- Female patients must meet one of the following conditions:
- Male patients and their partners must use effective contraception throughout the study period and up to 4 weeks after leaving the study.
Key exclusion criteria (18 listed)
- History of allergy to liposomes or amphotericin B.
- Received systemic treatment of amphotericin B or amphotericin B-containing formulation within 10 days prior to enrollment.
- Liposome used within 1 month before the signing informed consent.
- Confirmed or clinically diagnosed invasive fungal infection or known uncontrolled bacteremia or sepsis at screening.
- Eastern Cooperative Oncology Group (ECOG) performance status ≥3;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amphotericin B liposomesAmphotericin B liposomes for injection, 3 mg/kg, qd, IV | Drug | Amphotericin B liposomes |
Primary outcome
Overall success rate
Time frame: From the initiation of the third dose to 7 days after the last dose
A successful outcome is defined as fulfilling all components of a prespecified 5-part composite endpoint.
8 secondary outcomes
Percentage of patients without new fungal infections from the initiation of the first dose to 7 days after the last dose
Time frame: From the initiation of the third dose to 7 days after the last dose
Percentage of patients survived from the initiation of the first dose to 7 days after the last dose
Time frame: From the initiation of the third dose to 7 days after the last dose
Percentage of patients without discontinuation of study drug due to side effects or lack of efficacy during the treatment period
Time frame: From the initiation of the third dose to 7 days after the last dose
Percentage of patients experienced fever reduction during neutropenia after initiation of treatment
Time frame: From the initiation of the third dose to 7 days after the last dose
Percentage of patients with complete or partial remission of confirmed or clinically diagnosed IFD (baseline fungal infection) at the end of treatment
Time frame: From the initiation of the third dose to 7 days after the last dose
Adverse events
Time frame: From the screening period to 14 days after the last dose
Pharmacokinetic profile of amphotericin B
Time frame: Pre-dose and multiple timepoints up to 4 hours of the last dose
Pharmacokinetic profile of amphotericin B
Time frame: Pre-dose and multiple timepoints up to 4 hours of the last dosePharmacokinetic profile of amphotericin B, Such as "Area under the plasma concentration versus time curve (AUC)"
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Amphotericin B liposomes in people with Neutropenia and Fever, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xuefang Xia (+86-010-63932012, xiaxuefang@mail.ecspc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall success rate (time frame: From the initiation of the third dose to 7 days after the last dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2021.