Invasive Mold DiseasesNCT07725874
Safety and Efficacy of Liposomal Amphotericin B for Patients With Invasive Mold Diseases in Liver Transplant Recipients
A study testing AmBisome (Amphotericin B) Liposome in people with Invasive Mold Diseases, run by Beijing Friendship Hospital.
Trial summary
Invasive mold diseases (IMD) carry extremely high mortality rates in liver transplant recipients (aspergillosis prevalence ~1.8%, mortality 60%-90%; mucormycosis prevalence ~2%, mortality 38%-95%). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Invasive Mold Diseases
- What is being tested?
- AmBisome (Amphotericin B) Liposome
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 8 Aug 2026to 15 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients aged ≥12 years. Liver transplant recipients. Proven or probable invasive mold disease (IMD) according to the 2020 EORTC/MSGERC criteria.
- Have received at least one dose of liposomal amphotericin B (AmBisome) or voriconazole.
Who cannot join
- History of invasive mold disease previously treated with amphotericin B for more than 5 days.
- Documented hypersensitivity or allergy to amphotericin B formulations. Sequential Organ Failure Assessment (SOFA) score >15. Expected survival <72 hours. Pregnant or breastfeeding. Patients who, in the investigator's judgment, are unable to complete the study treatment or follow the study protocol.
- Recipients of combined organ transplantation or multivisceral transplantation.
About this study
Invasive mold diseases (IMD) carry extremely high mortality rates in liver transplant recipients (aspergillosis prevalence ~1.8%, mortality 60%-90%; mucormycosis prevalence ~2%, mortality 38%-95%). Guidelines emphasize early antifungal therapy: liposomal amphotericin B (L-AmB) is the first-line choice in liver insufficiency; voriconazole remains the gold standard for aspergillosis (but ineffective against mucormycosis), yet its use is limited by significant drug-drug interactions-requiring a 50%-60% dose reduction of calcineurin inhibitors and contraindicated with sirolimus-thereby increasing the risk of graft rejection. Currently, no head-to-head clinical trials compare voriconazole and L-AmB in liver transplant recipients with IMD. Therefore, a prospective real-world study is planned to generate robust data to support updates to international or Chinese guidelines.
Read the detailed description
Invasive mold diseases (IMD) represent a significant cause of morbidity and mortality among solid organ transplant (SOT) recipients. Liver transplant recipients are at heightened risk for developing IMD due to complex biliary-enteric anastomosis and underlying immunological deficits associated with liver dysfunction and the need for immunosuppressive therapy. Among SOT patients, invasive aspergillosis is the second most common invasive fungal infection and poses a substantial mortality risk, especially for those who have undergone liver transplantation. Current research indicates that 1.8% of liver transplant recipients develop invasive aspergillosis, with mortality rates reported between 60% and 90%.
While mucormycosis is less prevalent than invasive aspergillosis-accounting for approximately 2% of fungal infections in SOT recipients-it is associated with a poor prognosis, with mortality rates ranging from 38% to 95% in this population. These statistics highlight the critical need for effective antifungal therapies in the management of IMD among liver transplant patients.
Guidance from the 2019 American Society of Transplantation Infectious Diseases Community of Practice (ASTIDCOP) underscores the importance of early antifungal therapy initiation to optimize outcomes for SOT recipients affected by invasive aspergillosis. The primary antifungal drug classes used for treating invasive aspergillosis include polyenes, triazoles, and echinocandins. In the context of liver insufficiency, liposomal amphotericin B (L-AmB) is typically considered the first-line therapeutic option.
For mucormycosis, the 2019 guidelines from the European Confederation of Medical Mycology (ECMM) and the Mycoses Study Group Education and Research Consortium (MSGERC) recommend liposomal amphotericin B (L-AmB) as the first-line treatment. However, there are currently no international guidelines specifically addressing the management of mucormycosis in solid organ transplant recipients.
Voriconazole remains the preferred agent for treating invasive aspergillosis and is considered the standard of care. Lipid formulations of L-AmB are regarded as alternative treatment options for invasive aspergillosis. However, voriconazole is not recommended for the treatment of mucormycosis. Although voriconazole, a triazole antifungal agent, offers broad-spectrum activity against various yeast and mold species and is the current gold standard for invasive aspergillosis, its use is constrained by drug-drug interactions and safety concerns.
Liver function has a significant impact on the pharmacokinetics of antifungal agents, which is particularly relevant in liver transplant recipients. Both cyclosporine and tacrolimus are extensively metabolized by CYP3A4 and CYP3A5, necessitating a 50% to 60% reduction in the dosage of these calcineurin inhibitors when administered with voriconazole. The coadministration of voriconazole with sirolimus is contraindicated. Reducing the dose of immunosuppressive agents may increase the risk of graft rejection, presenting a therapeutic challenge in this patient population.
No direct head-to-head clinical trials have compared voriconazole and AmBisome for treating invasive mold infections in liver transplant recipients, especially regarding adverse reactions. This prospective, bigger scale, real-world study aims to fill the gap by evaluating both drugs such as IMD patients with liver transplantation to facilitate robust scientific data support for updated international or Chinese guideline
- Conditions
- Invasive Mold Diseases
- Being tested
- AmBisome (Amphotericin B) Liposome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmBisome (Amphotericin B) LiposomeDrug
This intervention is applied prospectively to the AmBisome group (target enrollment: 60 patients). The study does not mandate a fixed dose or fixed course length; rather, it reflects real-world clinical practice. All safety parameters (hepatotoxicity, nephrotoxicity, hypokalemia, cardiotoxicity, infusion reactions, tacrolimus dose/concentration changes, and serious adverse events) are longitudinally monitored during the intervention period.
| Study group | Role | What they receive |
|---|---|---|
| evaluate the safety of liposomal amphotericin B (AmBisome) in liver transplant recipients with IMD | Experimental | This study aims to describe the safety profiles and clinical characteristics of liposomal amphotericin B (AmBisome) or voriconazole as first-line therapies for invasive mold disease (IMD) in liver transplant recipients, utilizing historical matched-control analysis across 10 study sites. Specifically, a 1:2 propensity score matching (PSM) method will be applied to compare the prospectively enrolled AmBisome group (60 patients) with a historical voriconazole group (120 patients). The primary safety endpoints include: nephrotoxicity, hepatotoxicity, hypokalemia, cardiotoxicity (QT interval changes), infusion-related reactions, tacrolimus dose and trough concentration changes, and treatment-related serious adverse events leading to discontinuation or death (graded per CTCAE v5.0). Receives: Drug: AmBisome (Amphotericin B) Liposome |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of this study is the safety profile of liposomal amphotericin B (AmBisome) in liver transplant recipients with invasive mold disease
The primary endpoint of this study is to comprehensively evaluate the safety profile of liposomal amphotericin B (AmBisome) in liver transplant recipients diagnosed with invasive mold disease (IMD). Safety will be assessed by systematically monitoring the incidence, severity, timing, and outcomes of treatment-emergent adverse events (TEAEs) occurring during and after AmBisome therapy. Particular attention will be paid to adverse events of special interest associated with amphotericin B treatment, including nephrotoxicity, electrolyte disturbances (such as hypokalemia and hypomagnesemia), infusion-related reactions, hepatotoxicity, hematologic abnormalities, and other clinically significant laboratory abnormalities.
Measured: The comprehensive assessment for the primary safety endpoint will be performed at Week 6 (±7 days) after the initiation of antifungal therapy. If a patient prematurely discontinues treatment for any reason, the assessment time point will be at the time o
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start8 Aug 2026 (estimated)
- Primary completion15 May 2028 (estimated)
- Study completion15 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Mold DiseasesStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07725874
- Sponsor's protocol ID
- BFH20260625003
- Status last verified
- Jun 2026
- First submitted
- 9 Jul 2026
- Last updated
- 24 Jul 2026
- 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 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Liposomal Amphotericin B for Patients With Invasive Mold Diseases in Liver Transplant Recipients
- ClinicalTrials.gov ID
- NCT07725874
- Acronym / sponsor ID
- BFH20260625003
- Conditions
- Invasive Mold Diseases
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 8 Aug 2026 (estimated)
- Primary completion
- 15 May 2028 (estimated)
- Study completion
- 15 Aug 2028 (estimated)
- First posted
- 24 Jul 2026 (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.
Invasive mold diseases (IMD) carry extremely high mortality rates in liver transplant recipients (aspergillosis prevalence ~1.8%, mortality 60%-90%; mucormycosis prevalence ~2%, mortality 38%-95%). Guidelines emphasize early antifungal therapy: liposomal amphotericin B (L-AmB) is the first-line choice in liver insufficiency; voriconazole remains the gold standard for aspergillosis (but ineffective against mucormycosis), yet its use is limited by significant drug-drug interactions-requiring a 50%-60% dose reduction of calcineurin inhibitors and contraindicated with sirolimus-thereby increasing the risk of graft rejection. Currently, no head-to-head clinical trials compare voriconazole and L-AmB in liver transplant recipients with IMD. Therefore, a prospective real-world study is planned to generate robust data to support updates to international or Chinese guidelines.
Detailed description
Invasive mold diseases (IMD) represent a significant cause of morbidity and mortality among solid organ transplant (SOT) recipients. Liver transplant recipients are at heightened risk for developing IMD due to complex biliary-enteric anastomosis and underlying immunological deficits associated with liver dysfunction and the need for immunosuppressive therapy. Among SOT patients, invasive aspergillosis is the second most common invasive fungal infection and poses a substantial mortality risk, especially for those who have undergone liver transplantation. Current research indicates that 1.8% of liver transplant recipients develop invasive aspergillosis, with mortality rates reported between 60% and 90%.
While mucormycosis is less prevalent than invasive aspergillosis-accounting for approximately 2% of fungal infections in SOT recipients-it is associated with a poor prognosis, with mortality rates ranging from 38% to 95% in this population. These statistics highlight the critical need for effective antifungal therapies in the management of IMD among liver transplant patients.
Guidance from the 2019 American Society of Transplantation Infectious Diseases Community of Practice (ASTIDCOP) underscores the importance of early antifungal therapy initiation to optimize outcomes for SOT recipients affected by invasive aspergillosis. The primary antifungal drug classes used for treating invasive aspergillosis include polyenes, triazoles, and echinocandins. In the context of liver insufficiency, liposomal amphotericin B (L-AmB) is typically considered the first-line therapeutic option.
For mucormycosis, the 2019 guidelines from the European Confederation of Medical Mycology (ECMM) and the Mycoses Study Group Education and Research Consortium (MSGERC) recommend liposomal amphotericin B (L-AmB) as the first-line treatment. However, there are currently no international guidelines specifically addressing the management of mucormycosis in solid organ transplant recipients.
Voriconazole remains the preferred agent for treating invasive aspergillosis and is considered the standard of care. Lipid formulations of L-AmB are regarded as alternative treatment options for invasive aspergillosis. However, voriconazole is not recommended for the treatment of mucormycosis. Although voriconazole, a triazole antifungal agent, offers broad-spectrum activity against various yeast and mold species and is the current gold standard for invasive aspergillosis, its use is constrained by drug-drug interactions and safety concerns.
Liver function has a significant impact on the pharmacokinetics of antifungal agents, which is particularly relevant in liver transplant recipients. Both cyclosporine and tacrolimus are extensively metabolized by CYP3A4 and CYP3A5, necessitating a 50% to 60% reduction in the dosage of these calcineurin inhibitors when administered with voriconazole. The coadministration of voriconazole with sirolimus is contraindicated. Reducing the dose of immunosuppressive agents may increase the risk of graft rejection, presenting a therapeutic challenge in this patient population.
No direct head-to-head clinical trials have compared voriconazole and AmBisome for treating invasive mold infections in liver transplant recipients, especially regarding adverse reactions. This prospective, bigger scale, real-world study aims to fill the gap by evaluating both drugs such as IMD patients with liver transplantation to facilitate robust scientific data support for updated international or Chinese guideline
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| evaluate the safety of liposomal amphotericin B (AmBisome) in liver transplant recipients with IMD | Experimental | Drug: AmBisome (Amphotericin B) LiposomeThis study aims to describe the safety profiles and clinical characteristics of liposomal amphotericin B (AmBisome) or voriconazole as first-line therapies for invasive mold disease (IMD) in liver transplant recipients, utilizing historical matched-control analysis across 10 study sites. Specifically, a 1:2 propensity score matching (PSM) method will be applied to compare the prospectively enrolled AmBisome group (60 patients) with a historical voriconazole group (120 patients). The primary safety endpoints include: nephrotoxicity, hepatotoxicity, hypokalemia, cardiotoxicity (QT interval changes), infusion-related reactions, tacrolimus dose and trough concentration changes, and treatment-related serious adverse events leading to discontinuation or death (graded per CTCAE v5.0). |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged ≥12 years. Liver transplant recipients. Proven or probable invasive mold disease (IMD) according to the 2020 EORTC/MSGERC criteria.
- Have received at least one dose of liposomal amphotericin B (AmBisome) or voriconazole.
Key exclusion criteria (3 listed)
- History of invasive mold disease previously treated with amphotericin B for more than 5 days.
- Documented hypersensitivity or allergy to amphotericin B formulations. Sequential Organ Failure Assessment (SOFA) score >15. Expected survival <72 hours. Pregnant or breastfeeding. Patients who, in the investigator's judgment, are unable to complete the study treatment or follow the study protocol.
- Recipients of combined organ transplantation or multivisceral transplantation.
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 |
|---|---|---|
| AmBisome (Amphotericin B) LiposomeThis intervention is applied prospectively to the AmBisome group (target enrollment: 60 patients). The study does not mandate a fixed dose or fixed course length; rather, it reflects real-world clinical practice. All safety parameters (hepatotoxicity, nephrotoxicity, hypokalemia, cardiotoxicity, infusion reactions, tacrolimus dose/concentration changes, and serious adverse events) are longitudinally monitored during the intervention period. | Drug | evaluate the safety of liposomal amphotericin B (AmBisome) in liver transplant recipients with IMD |
Primary outcome
The primary endpoint of this study is the safety profile of liposomal amphotericin B (AmBisome) in liver transplant recipients with invasive mold disease
Time frame: The comprehensive assessment for the primary safety endpoint will be performed at Week 6 (±7 days) after the initiation of antifungal therapy. If a patient prematurely discontinues treatment for any reason, the assessment time point will be at the time o
The primary endpoint of this study is to comprehensively evaluate the safety profile of liposomal amphotericin B (AmBisome) in liver transplant recipients diagnosed with invasive mold disease (IMD). Safety will be assessed by systematically monitoring the incidence, severity, timing, and outcomes of treatment-emergent adverse events (TEAEs) occurring during and after AmBisome therapy. Particular attention will be paid to adverse events of special interest associated with amphotericin B treatment, including nephrotoxicity, electrolyte disturbances (such as hypokalemia and hypomagnesemia), infusion-related reactions, hepatotoxicity, hematologic abnormalities, and other clinically significant laboratory abnormalities.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing AmBisome (Amphotericin B) Liposome in people with Invasive Mold Diseases, run by Beijing Friendship Hospital.
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 3 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: opening soon, as of the sponsor's last update on 24 Jul 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
The primary endpoint of this study is the safety profile of liposomal amphotericin B (AmBisome) in liver transplant recipients with invasive mold disease (time frame: The comprehensive assessment for the primary safety endpoint will be performed at Week 6 (±7 days) after the initiation of antifungal therapy. If a patient prematurely discontinues treatment for any reason, the assessment time point will be at the time o). 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 24 Jul 2026.