A Phase 4 interventional study of Micafungin in Aspergillosis and Candidiasis, sponsored by Astellas Pharma China, Inc.. Terminated at 16 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-07.
Sponsored by Astellas Pharma China, Inc. (part of Astellas Pharma Inc) · Phase 4, Interventional, and Treatment
The objective of this study is to evaluate the safety and efficacy of intravenous micafungin for the treatment of adult patients in China infected by Candida spp or Aspergillus spp.
134 studies on the registry are indexed under Aspergillosis; 10 are open to participants now.
This study's enrollment of 105 is above the median of 47 across 75 interventional studies indexed under Aspergillosis.
Browse Aspergillosis studies →Astellas Pharma China, Inc. is the lead sponsor of 24 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intravenous (IV)
Drug: Micafungin
Injection
Safety as assessed by overall incidence and severity of adverse events for patients with candidiasis
Time frame: Up to a maximum of 10 weeks
Safety as assessed by overall incidence and severity of adverse events for patients with aspergillosis
Time frame: Up to a maximum of 14 weeks
Safety as assessed by adverse reactions for patients with candidiasis
Time frame: Up to a maximum of 10 weeks
Safety as assessed by adverse reactions for patients with aspergillosis
Time frame: Up to a maximum of 14 weeks
Overall success rate for patients with candidiasis
Overall success rate=number of overall success patients/number of patients for efficacy evaluation × 100% at end of treatment (overall success is defined as patients with complete or partial response)
Time frame: End of treatment (up to up to 4 weeks, and up to 8 weeks for patients with chronic disseminated candidiasis, candida osteomyelitis, or candida endocarditis)
Overall success rate for patients with aspergillosis
Overall success rate=number of overall success patients/number of patients for efficacy evaluation × 100% at end of treatment (overall success is defined as patients with complete or partial response)
Time frame: End of treatment (up to 6 weeks, and up to 12 weeks for refractory patients)
Clinical Improvement rate for patients with candidiasis
Time frame: End of treatment (up to up to 4 weeks, and up to 8 weeks for patients with chronic disseminated candidiasis, candida osteomyelitis, or candida endocarditis
Clinical Improvement rate for patients with aspergillosis
Time frame: End of treatment (up to 6 weeks, and up to 12 weeks for refractory patients)
Fungal clearance rate for patients with candidiasis
Time frame: End of treatment (up to 4 weeks, and up to 8 weeks for patients with chronic disseminated candidiasis, candida osteomyelitis, or candida endocarditis)
Fungal clearance rate for patients with aspergillosis
Time frame: End of treatment (up to 6 weeks, and up to 12 weeks for refractory patients
Fatality rate for patients with candidiasis
Time frame: End of treatment (up to 4 weeks, and up to 8 weeks for patients with chronic disseminated candidiasis, candida osteomyelitis, or candida endocarditis)
Fatality rate for patients with aspergillosis
Time frame: End of treatment (up to 6 weeks, and up to 12 weeks for refractory patients
Safety as assessed by relationship of adverse events to Micafungin for patients with candidiasis
Time frame: Day 1 to the end of treatment (up to 4 weeks, and up to 8 weeks for patients with chronic disseminated candidiasis, candida osteomyelitis, or candida endocarditis)
Safety as assessed by relationship of adverse events to Micafungin for patients with aspergillosis
Time frame: Day 1 to the end of treatment (up to 6 weeks, and up to 12 weeks for refractory patients)
Safety as assessed by liver and kidney function for patients with candidiasis
Time frame: Day 1 to the end of treatment (up to 4 weeks, and up to 8 weeks for patients with chronic disseminated candidiasis, candida osteomyelitis, or candida endocarditis)
Safety as assessed by liver and kidney function for patients with aspergillosis
Time frame: Day 1 to the end of treatment (up to 6 weeks, and up to 8 weeks, and up to 12 weeks for refractory patients)
Plan to share: No — Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Ran from Mar 2014 to primary completion in Dec 2014, 9 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Micafungin