Liver TransplantationPhase 4NCT04728971
To Evaluate the Efficacy and Safety of Micafungin in Preventing Invasive Mycosis After Liver Transplantation
A Phase 4 study testing Micafungin Sodium 50 MG Injection and Caspofungin Acetate in people with Liver Transplantation, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.
Trial summary
To evaluate the clinical success rate of micafungin in preventing invasive mycosis after liver transplantation. Read more about this study
- Who is it for?
- Ages 60 to 65 years
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- Micafungin Sodium 50 MG Injection and Caspofungin Acetate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to 1 Feb 2026
- Phase
- Phase 4
- 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 60 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign the informed consent form voluntarily;
- Liver transplant patients with 1 high-risk factor; A. Transplant again; B. Fulminant liver failure; C. Renal failure requires alternative treatment (defined as creatinine clearance ≤40 ml/min); D. ICU duration before liver transplantation≥48h; E. Have received abdominal surgery within one month before liver transplantation or; F. Common bile duct jejunostomy (except for children); G. Excessive blood transfusion (blood transfusion exceeds 2000mL); H. The donor's ICU hospital stay exceeds 5 days; I. Positive sputum and blood culture of the donor J. The donor has evidence of lung or bloodstream infection (pulmonary infection is evaluated according to the diagnostic criteria and treatment principles (draft) of invasive lung fungal infection, and bloodstream infection is evaluated according to invasive fungal disease of patients with hematopathy/malignant tumor Diagnostic criteria and treatment principles (fifth revised edition) for evaluation) K. 60 years old ≤ age ≤ 65 years old
Who cannot join
- Have used other investigational drugs or are participating in other clinical trials within 4 weeks before enrollment;
- Currently combined with any kind of fungal infection;
- Allergic to study drugs;
- Joint transplantation;
- Women who are pregnant, preparing to become pregnant or breast-feeding;
- The investigator thinks that it is not suitable to use the test drug.
About this study
To evaluate the clinical success rate of micafungin in preventing invasive mycosis after liver transplantation.
- Conditions
- Liver Transplantation
- Being tested
- Micafungin Sodium 50 MG Injection, Caspofungin Acetate
- Keywords
- Micafungin, Invasive Mycosis, Prevention
- Medical subject headings
- Invasive Fungal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micafungin Sodium 50 MG InjectionDrug
Give Micafungin 150 mg/d within 24 hours after liver transplantation.
Caspofungin AcetateDrug
Give Caspofungin 35 mg/d lasts 1 week after liver transplantation.
| Study group | Role | What they receive |
|---|---|---|
| Micafungin Preventing Group | Experimental | Not described Receives: Drug: Micafungin Sodium 50 MG Injection |
| Others Preventing Group | Active comparator | Not described Receives: Drug: Caspofungin Acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-transplant infections
Frequency of clinically or microbiologically documented infection after transplantation.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start1 Oct 2022 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Zhong, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04728971
- Sponsor's protocol ID
- SHLTQC-4
- Status last verified
- Aug 2022
- First submitted
- 26 Jan 2021
- Last updated
- 16 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Efficacy and Safety of Micafungin in Preventing Invasive Mycosis After Liver Transplantation
- ClinicalTrials.gov ID
- NCT04728971
- Acronym / sponsor ID
- SHLTQC-4
- Conditions
- Liver Transplantation
- Keywords
- Micafungin, Invasive Mycosis, Prevention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 28 Jan 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.
To evaluate the clinical success rate of micafungin in preventing invasive mycosis after liver transplantation.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Micafungin Preventing Group | Experimental | Drug: Micafungin Sodium 50 MG Injection |
| Others Preventing Group | Active comparator | Drug: Caspofungin Acetate |
Who may qualify
- Ages
- 60 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Sign the informed consent form voluntarily;
- Liver transplant patients with 1 high-risk factor; A. Transplant again; B. Fulminant liver failure; C. Renal failure requires alternative treatment (defined as creatinine clearance ≤40 ml/min); D. ICU duration before liver transplantation≥48h; E. Have received abdominal surgery within one month before liver transplantation or; F. Common bile duct jejunostomy (except for children); G. Excessive blood transfusion (blood transfusion exceeds 2000mL); H. The donor's ICU hospital stay exceeds 5 days; I. Positive sputum and blood culture of the donor J. The donor has evidence of lung or bloodstream infection (pulmonary infection is evaluated according to the diagnostic criteria and treatment principles (draft) of invasive lung fungal infection, and bloodstream infection is evaluated according to invasive fungal disease of patients with hematopathy/malignant tumor Diagnostic criteria and treatment principles (fifth revised edition) for evaluation) K. 60 years old ≤ age ≤ 65 years old
Key exclusion criteria (6 listed)
- Have used other investigational drugs or are participating in other clinical trials within 4 weeks before enrollment;
- Currently combined with any kind of fungal infection;
- Allergic to study drugs;
- Joint transplantation;
- Women who are pregnant, preparing to become pregnant or breast-feeding;
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 |
|---|---|---|
| Micafungin Sodium 50 MG InjectionGive Micafungin 150 mg/d within 24 hours after liver transplantation. | Drug | Micafungin Preventing Group |
| Caspofungin AcetateGive Caspofungin 35 mg/d lasts 1 week after liver transplantation. | Drug | Others Preventing Group |
Primary outcome
Post-transplant infections
Time frame: 90 days
Frequency of clinically or microbiologically documented infection after transplantation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Micafungin Sodium 50 MG Injection and Caspofungin Acetate in people with Liver Transplantation, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.
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 2 inclusion and 6 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 16 Aug 2022. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-transplant infections (time frame: 90 days). 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 16 Aug 2022; AzTrials last refreshed its copy on 8 Nov 2026.