A Phase 1 interventional study of Micafungin in Oropharyngeal Candidiasis, Candidemia and Invasive Candidiasis, sponsored by Astellas Pharma Inc. Completed at 13 sites in 2 countries. Open to participants aged 2 Years to 16 Years. Per ClinicalTrials.gov, last updated 2024-11-18.
Sponsored by Astellas Pharma Inc · Phase 1, Interventional, and Other
Children with fungal infections will be divided into two groups by weight. Children weighing \< 25 kg will receive a higher dose of study medication (per kg body weight) for 10 to 14 days than children weighing > 25 kg.
This is a prospective, multicenter, open-label, repeat-dose study conducted in two groups. Subjects in Group 1 and Group 2 will receive treatment for 10 to 14 days (per investigator clinical judgment); dose level (3.0 mg/kg or 4.5 mg/kg) will be determined by the subject's weight at baseline. Study procedures in both groups will be similar except that serial blood samples for assessment of pharmacokinetics will be collected in Group 1. Subjects may only participate in one group of the study.
At least 24 subjects, with at least 8 in each of three age ranges, will be enrolled in Group 1 (PK + safety). At least 36 subjects will be enrolled in Group 2 (safety), with at least 12 in each of the three age ranges.
73 studies on the registry are indexed under Candidemia; 5 are open to participants now.
This study's enrollment of 84 is above the median of 63 across 44 interventional studies indexed under Candidemia.
Browse Candidemia studies →Astellas Pharma Inc is the lead sponsor of 525 studies on the registry; 4 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 19 (68%) have results posted.
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.
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.
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.
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.
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.
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.
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.
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.
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.
IV
Drug: Micafungin
IV
Drug: Micafungin
IV
Also known as: FK463
PK parameters (AUCtau, Tmax, and Cmax)
Time frame: 10 - 14 Days
Adverse events
Time frame: Day 1 to End of Study
Vital signs
Time frame: Day 1 to End of Study
Hematology and chemistry laboratory tests
Time frame: Day 1 to End of Study
12-lead ECGs and Physical examination
Time frame: Day 1 to End of Study
Plan to share: Yes — Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Access criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Data sharing details ↗ · www.clinicaltrials.astellas.com
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Micafungin