Liver Transplant RecipientPhase 3KOPINNCT01974375
Micafungin Versus Fluconazole for Prevention of Invasive Fungal Disease in Living Donor Liver Transplant Recipients
A Phase 3 study testing micafungin and Fluconazole in people with Liver Transplant Recipient, run by Asan Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to demonstrate non-inferiority of micafungin at a dose of 100 mg/day versus fluconzeole for the prevention of Invasive Fungal Disease, defined according to the revised EORTC/MSG criteria, undergoing living-donor liver transplantation. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Liver Transplant Recipient
- What is being tested?
- micafungin and Fluconazole
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2012to Dec 2014
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 20 years.
- Undergoing Living Donor Liver Transplantation(LDLT)
Who cannot join
- Any systemic antifungal therapy (excluding fluconazole or SDD for a maximum of 7 days) within 14 days prior to randomization.
- Evidence of documented ('proven' or 'probable') or suspected ('possible') IFD (according to the EORTC/MSG criteria).
- Allergy, hypersensitivity, or any serious reaction to an echinocandin antifungal, or any of the study drugs or their excipients.
- Reimplantation or orthotopic transplantation patient.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, Seoul, 138-736
Giwon Song, Professor, +82-10-8794-8701, drsong71@hotmail.com
About this study
Official title: Randomized, Open Label, Non-inferiority Study of Micafungin Versus Fluconazole for the Korean Prevention of Invasive Fungal Disease in Living Donor Liver Transplant Recipients
The purpose of this study is to demonstrate non-inferiority of micafungin at a dose of 100 mg/day versus fluconzeole for the prevention of Invasive Fungal Disease, defined according to the revised EORTC/MSG criteria, undergoing living-donor liver transplantation.
Read the detailed description
This is Randomized, Open label, Non-inferiority Study of Micafungin versus Fluconazole for the Korean Prevention of Invasive Fungal Disease in Living Donor Liver Transplant Recipients
After transplant subjects will be randomized to one of the following treatment arms:
- Micafungin 100 mg/day intravenous (2.0 mg/kg/day in subjects weighing <40 kg)
- Fluconazole 100~200mg/day, IV care until oral medication becomes possible
Stratification according to centers. Antifungal prophylaxis will be administered once daily for a period of 21 days, or until hospital discharge, whichever occurs first.
This is an open label study; Study center personnel will not be blinded to treatment.
- Conditions
- Liver Transplant Recipient
- Being tested
- micafungin, Fluconazole
- Keywords
- Living donor, Liver transplant, antifungal prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
micafunginDrug
Also called Mycamine
Micafungin 100 mg/day intravenous (2.0 mg/kg/day in subjects weighing <40 kg)
FluconazoleDrug
Fluconazole 100~200mg/day, IV care until oral medication becomes possible
| Study group | Role | What they receive |
|---|---|---|
| micafungin | Experimental | micafungin sodium IV (Mycamine®) Receives: Drug: micafungin |
| Fluconazole | Active comparator | Fluconazole IV (use same brand in each hospital) Receives: Drug: Fluconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of invasive fungal disease
To demonstrate non-inferiority of micafungin at a dose of 100 mg/day versus fluconzeole for the prevention of Invasive Fungal Disease, defined according to the revised EORTC/MSG criteria, undergoing living-donor liver transplantation.
'Clinical success' at the End of Prophylaxis as assessed by the investigator.
Absence of a 'proven' or 'probable' IFD AND No initiation of antifungal treatment (additional antifungal medication or increase in the dose of the study drug due to lack of efficacy)
Measured: 6 months
Secondary outcomes (6)
no events of proven/probable IFD
no events of proven/probable IFD at end of prophylaxis visit and end of study visit
Measured: 6 months
ime to proven/probable IFD
Time to proven/probable IFD
Measured: 6 months
fungal-free survival
fungal-free survival et end of study/and long-term follow-up visit
Measured: 6 months
incidence of superficial mycosis infection and colonization
incidence of superficial mycosis infection and colonization at the end of prophylaxis compare to baseline
Measured: 6 months
saftey by variables
saftey by variables of viatl sign/physical examination/laboratory test
Measured: 6 months
cases of adverse events
cases of adverse events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2013 (estimated)
- Study startAug 2012
- Primary completionJun 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver Transplant RecipientStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giwon Song, Asan Medical Center
- Investigators
- SUNG-GYU LEE, Professor, Principal investigator, Asan Medical CenterGiwon Song, Professor, Principal investigator, Asan Medical CenterNamjoon Lee, Professor, Principal investigator, Seoul National UniversityJaewon Joh, Professor, Principal investigator, Samsung Medical CenterDong-Lak Choi, Professor, Principal investigator, Daegu Catholic University Medical CenterMyung Soo Kim, professor, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01974375
- Sponsor's protocol ID
- MYC-LT-01
- Acronym
- KOPIN
- Status last verified
- Oct 2013
- First submitted
- 18 Oct 2013
- Last updated
- 1 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kang WH, Song GW, Lee SG, Suh KS, Lee KW, Yi NJ, Joh JW, Kwon CHD, Kim JM, Choi DL, Kim JD, Kim MS. A Multicenter, Randomized, Open-Label Study to Compare Micafungin with Fluconazole in the Prophylaxis of Invasive Fungal Infections in Living-Donor Liver Transplant Recipients. J Gastrointest Surg. 2020 Apr;24(4):832-840. doi: 10.1007/s11605-019-04241-w. Epub 2019 May 7.
PubMed 31066013
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open Label, Non-inferiority Study of Micafungin Versus Fluconazole for the Korean Prevention of Invasive Fungal Disease in Living Donor Liver Transplant Recipients
- ClinicalTrials.gov ID
- NCT01974375
- Acronym / sponsor ID
- KOPIN / MYC-LT-01
- Conditions
- Liver Transplant Recipient
- Keywords
- Living donor, Liver transplant, antifungal prevention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 1 Nov 2013 (estimated)
- 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.
The purpose of this study is to demonstrate non-inferiority of micafungin at a dose of 100 mg/day versus fluconzeole for the prevention of Invasive Fungal Disease, defined according to the revised EORTC/MSG criteria, undergoing living-donor liver transplantation.
Detailed description
This is Randomized, Open label, Non-inferiority Study of Micafungin versus Fluconazole for the Korean Prevention of Invasive Fungal Disease in Living Donor Liver Transplant Recipients
After transplant subjects will be randomized to one of the following treatment arms:
- Micafungin 100 mg/day intravenous (2.0 mg/kg/day in subjects weighing <40 kg)
- Fluconazole 100~200mg/day, IV care until oral medication becomes possible
Stratification according to centers. Antifungal prophylaxis will be administered once daily for a period of 21 days, or until hospital discharge, whichever occurs first.
This is an open label study; Study center personnel will not be blinded to treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| micafungin | Experimental | Drug: micafunginmicafungin sodium IV (Mycamine®) |
| Fluconazole | Active comparator | Drug: FluconazoleFluconazole IV (use same brand in each hospital) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 20 years.
- Undergoing Living Donor Liver Transplantation(LDLT)
Key exclusion criteria (4 listed)
- Any systemic antifungal therapy (excluding fluconazole or SDD for a maximum of 7 days) within 14 days prior to randomization.
- Evidence of documented ('proven' or 'probable') or suspected ('possible') IFD (according to the EORTC/MSG criteria).
- Allergy, hypersensitivity, or any serious reaction to an echinocandin antifungal, or any of the study drugs or their excipients.
- Reimplantation or orthotopic transplantation patient.
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 |
|---|---|---|
| micafunginAlso: MycamineMicafungin 100 mg/day intravenous (2.0 mg/kg/day in subjects weighing <40 kg) | Drug | micafungin |
| FluconazoleFluconazole 100~200mg/day, IV care until oral medication becomes possible | Drug | Fluconazole |
Primary outcome
Prevention of invasive fungal disease
Time frame: 6 months
To demonstrate non-inferiority of micafungin at a dose of 100 mg/day versus fluconzeole for the prevention of Invasive Fungal Disease, defined according to the revised EORTC/MSG criteria, undergoing living-donor liver transplantation. 'Clinical success' at the End of Prophylaxis as assessed by the investigator. Absence of a 'proven' or 'probable' IFD AND No initiation of antifungal treatment (additional antifungal medication or increase in the dose of the study drug due to lack of efficacy)
6 secondary outcomes
no events of proven/probable IFD
Time frame: 6 months
ime to proven/probable IFD
Time frame: 6 months
fungal-free survival
Time frame: 6 months
incidence of superficial mycosis infection and colonization
Time frame: 6 months
saftey by variables
Time frame: 6 months
cases of adverse events
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2013.
- Derived from this study: PubMed 31066013Kang WH, Song GW, Lee SG, Suh KS, Lee KW, Yi NJ, Joh JW, Kwon CHD, Kim JM, Choi DL, Kim JD, Kim MS. A Multicenter, Randomized, Open-Label Study to Compare Micafungin with Fluconazole in the Prophylaxis of Invasive Fungal Infections in Living-Donor Liver Transplant Recipients. J Gastrointest Surg. 2020 Apr;24(4):832-840. doi: 10.1007/s11605-019-04241-w. Epub 2019 May 7.
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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.
SUNG-GYU LEE, Professor principal investigator
Asan Medical Center
Giwon Song, Professor principal investigator
Asan Medical Center
Namjoon Lee, Professor principal investigator
Seoul National University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing micafungin and Fluconazole in people with Liver Transplant Recipient, run by Asan Medical Center at 1 site in South Korea.
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 4 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 1 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Giwon Song, Professor (+82-10-8794-8701, drsong71@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevention of invasive fungal disease (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01974375, which also lists 1 linked publication.
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 1 Nov 2013.