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A study of mirabegron in young children with neurogenic detrusor overactivity

Mirabegron in Young Children Study | Astellas Clinical Trials

A study to learn how [14C]ASP0367 is processed by the body in healthy men

14C ASP0367 In Males Study | Astellas Clinical Trials

A Study of Gilteritinib (ASP2215) Combined with Chemotherapy in Children, Adolescents and Young Adults with FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

Gilteritnib and Chemotherapy Study | Astellas Clinical Trials

A study to find the best dose of ASP5354 to show lymph nodes in people with breast cancer or melanoma during surgery

ASP5354 to Show Lymph Nodes Study | Astellas Clinical Trials

A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)

Intravesical Enfortumab Vedotin for Bladder Cancer Study | Astellas Clinical Trials

A study of the safety and tolerability of ASP7317 in adults who are losing their clear, sharp central vision due to geographic atrophy secondary to dry age-related macular degeneration

ASP7317 for Geographic Atrophy Study | Astellas Clinical Trials

A Study to Assess the Antitumor Activity, Safety, Pharmacokinetics and Biomarkers of Zolbetuximab (IMAB362) in Participants with Claudin (CLDN) 18.2 Positive, Metastatic or Advanced Unresectable Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma

Zolbetuximab Study | Astellas Clinical Trials

A Study of an Intratumoral Oncolytic Virus in Patients with Advanced Metastatic Solid Tumors

Intratumoral Oncolytic Virus Study | Astellas Clinical Trials

A Study to Assess ASP0598 Otic Solution Following Topical Application in the Ear in Subjects with Chronic Tympanic Membrane Perforation (CTMP)

ASP058 Otic Solution Study | Astellas Clinical Trials

A study to evaluate ASP0367 in participants with primary mitochondrial myopathy

ASP0367 Study for Primary Mitochondrial Myopathy | Astellas Clinical Trials

A study of ASP2138 in adults with stomach cancer or pancreatic cancer

ASP2138 Study for Stomach or Pancreatic Cancer | Astellas Clinical Trials

A study about how ASP5354 affects the body in healthy adults and in adults whose kidneys do not work well

ASP5354 for Healthy Adults and Adults with Poor Kidneys | Astellas Clinical Trials

A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study

Prostate Cancer Study for Previous Participation in Enzalutamide  | Astellas Clinical Trials

A Study to Assess the Efficacy and Safety of IMAB362 in Combination with Nab-Paclitaxel and Gemcitabine (Nab-P + GEM) as First Line Treatment in Subjects with Claudin 18.2 (CLDN18.2) Positive, Metastatic Pancreatic Adenocarcinoma

IMAB362 with Nab P and GEM Study for Pancreatic Cancer  | Astellas Clinical Trials

A study of gilteritinib, venetoclax and azacitidine as a combined treatment for people newly diagnosed with acute myeloid leukemia

Gilteritinib Venetoclax and Azacitidine Study for Acute Myeloid Leukemia | Astellas Clinical Trials

A Study Investigating the Safety, Tolerability and Efficacy of ASP7517 in Subjects with Relapsed/Refractory Acute Myeloid Leukemia (AML) and Relapsed/Refractory Higher Risk Myelodysplastic Syndrome (MDS)

ASP7517 for Acute Myeloid Leukimia | Astellas Clinical Trials

A study to evaluate ASP0367 in participants with reduced maximum oxygen uptake due to poor systemic oxygen extraction

ASP0367 for Reduced Maxiumum Oxygen Uptake Study | Astellas Clinical Trials

A study of ASP3082 in adults with previously treated solid tumors

ASP3082 for Solid Tumors Study | Astellas Clinical Trials

A Study of ASP1570 in adults with locally advanced or metastatic solid tumors

ASP1570 for Advanced or Metastatic Tumors Study | Astellas Clinical Trials

Study of ASP7517 Alone and with Pembrolizumab in Participants with Advanced Solid Tumors Expressing WT1 Antigen

ASP7517 with Pembrolizumab Study | Astellas Clinical Trials

A Safety Surveillance Study in Subjects with Macular Degenerative Disease Treated with Human Embryonic Stem Cell-derived Retinal Pigment Epithelial Cell Therapy

Macular Degenerative Disease Study | Astellas Clinical Trials

A study to evaluate mirabegron in pediatric participants from 5 to less than 18 years of age with overactive bladder (OAB)

Mirabegron Study in Children with OAB Study | Astellas Clinical Trials

Study of ASP0739 Alone and with Pembrolizumab in Advanced Solid Tumors with NY-ESO-1 Expression Participants

ASP0739 with Pembrolizumab Study For Solid Tumors| Astellas Clinical Trials

A study of ASP0367 in people with kidneys that do not work well and in healthy people

ASP0367 Study for Adults with Poor Kidneys | Astellas Clinical Trials

Enfortumab vedotin and pembrolizumab vs. chemotherapy alone in untreated locally advanced or metastatic urothelial cancer

Enfortumab Vedotin and Pembrolizumab vs Chemotherapy Study | Astellas Clinical Trials

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Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.

Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.

9463-cl-2303-clrrs-02-disc01-en-final-02.pdf

9463-cl-2303-clls-disc01-en-final-02.pdf

The study will evaluate how effective and how safe the drug micafungin is when compared to the drug amphotericin B deoxycholate in treating neonates and young infants with certain fungal infections.

Study to compare the efficacy and safety of micafungin versus conventional amphotericin B for the treatment of neonatal candidiasis

Neonates and young infants will be stratified by estimated gestational age and by world region

CN CDE Number

EudraCT Number

jRCT Number

NCT ID

Patient Level Data

Product ST Name

Therapeutic Area

Link to results on Astellas Clinical Study Results Web site

UCLA Medical Center

Children’s Hospital of Orange County

Connecticut Children's NICU at University of Connecticut Health Center

Georgetown University Hospital

Dept of Pediatrics, University of Florida College of Medicine

Nemours Children's Clinic

Wesley Medical Center

Children's Hospital of Michigan

St John's Mercy Medical Center

Morristown Memorial Hospital

UMDNJ/Robert Wood Johnson Medical School

Westchester Medical Center

Duke University

WakeMed Health and Hospitals

Children's Hospital of Pittsburgh

The University of Texas Medical Branch

University of Texas Medical School

Baylor College of Medicine

University Of Utah

University of Virginia

Virginia Commonwealth University

Hospital De Ninos De Santa Fe Dr. Orlando Alassia

Hospital das Clínicas da Universidade Federal de Goiás

Irmandade da Santa Casa de Misericórdia de Belo Horizonte

Hospital de Clinicas do Parana

Pro Matre Paulista

Hospital de Base da Faculdade de Medicina

Hospital e Maternidade Santa Joana

Multiprofile Hospital for Active Treatment

Spec Hospital for Active Treatment of Children Diseases

First Municipal Hospital for Active Treatment-Sofia

McMaster Children's Hospital

Hospital for Sick Children

Hospital Padre Hurtado

Hospital Clinico de la Pontificia Universidad Catolica de Chile

Centro Medico Imbanaco

Hospital Pablo Tobon Uribe

Klinichiki Bolnicki Centar-Zagreb

'P&A Kyriakou' Childrens' General Hospital of Athens

Elena Venizelou hospital

University Hospital of Patras

Semmelweis Egyetem

Pándy Kálmán Megyei Kórház

BAZ County Hospital

Jósa András Oktató Kórház Nonprofit Kft.

Bnei Zion Medical Center

Rambam Medical Center

Edith Wolfson Medical Center

Hadassah University Hospital Ein Kerem

Tel Aviv Sourasky Medical Center

The Chaim Sheba Medical Center

Hospital Universitario "Dr. José Eleuterio Gonzalez" (Universidad Autonoma de Nuevo Leon)

Hospital Central Dr. Ignacio Morones Prieto

Hospital Nacional Cayetano Heredia

Hospital Nacional Arzobispo Loayza

Instituto Neuro Cardiovascular de las Américas

Philippine General Hospital

Prof. Dr. Alfred Rusescu Institute of Mother and Child Care

Emergency County Clinical Hospital

University of Limpopo

Taichung Veteran General Hospital

Cukurova University Medical Faculty

Istanbul University Faculty of Medicine

Kocaeli University Hospital

Community Institution "Regional Children Clinical Hospital"

Municipal Institution "Donetsk Regional Center of Mother and Child Care"

Lugansk Regional Childrens Clinical Hospital

Municipal Institution "Lviv City Clinical Childrens Hospital"

Municipal Institution “Odesa Regional Children's Hospital”

Vinnytsya Regional Children Clinical Hospital

A Phase 3, Randomized, Double-Blind, Multi-Center study to compare the efficacy and safety of Micafungin versus Amphotericin B Deoxycholate for the Treatment of Neonatal Candidiasis

Age Continuous

Age, Customized

Gender, Male/Female

Ethnicity (NIH/OMB)

Race/Ethnicity, Customized

Gestational Age

Study Specific Characteristic

Region of Enrollment

Birth Weight

Candidemia: diagnosed if Candida isolated from blood only; Invasive candidiasis: diagnosed if Candida isolated from blood in addition to other body fluids such as cerebrospinal fluid (CSF), peritoneal fluid, or urine.

Fungal Infection Type

End-organ dissemination was assessed using echocardiogram, abdominal ultrasound, including evaluation of the liver, spleen, and kidneys, head ultrasound, computed tomography (CT) or magnetic resonance imaging (MRI), and retinal exam (if clinically feasible). End-organ dissemination was assessed by the data review panel (DRP). Missing for the DRP assessment means that no evidence for EOD was documented.

Presence of End-Organ Dissemination (EOD)

Fungal-free survival was assessed by an independent data review panel (DRP). Fungal-free survival is defined as the percentage of participants alive at one week following the last dose of study drug with a mycological response of eradication and no requirement for alternative systemic antifungal therapy for continued treatment. Eradication was defined as culture or histologically documented absence of the infecting Candida species from all positive normally sterile sites during therapy, documented by 2 negative samples, drawn at least 24 hours apart, or for Candida meningitis and/or candiduria, 1 negative culture.

Full Analysis Set (all randomized infants who were administered any amount of study drug)

Fungal-free survival

Time to mycological clearance of invasive candidiasis is defined as the time from first dose to the day of mycological eradication for baseline invasive candidiasis infection. Eradication was defined as a culture or histologically documented absence of the infecting Candida species from all positive normally sterile sites during therapy, documented by 2 negative samples, drawn at least 24 hours apart, or for for Candida meningitis and/or candiduria, 1 negative culture. Infants without eradication during the treatment period and who survived were censored at one day after the end of treatment. Infants without eradication who died before completing the treatment period or were lost to follow-up during the treatment were censored at their death or last contact day.

Time to mycological clearance of invasive candidiasis

Fungal-free survival was assessed by an independent data review panel (DRP). Fungal-free survival is defined as the percentage of participants alive at the end of study drug therapy with a mycological response of eradication based upon the DRP assessment and no requirement for alternative systemic antifungal therapy for continued treatment.

Participants in the full analysis set with end-organ dissemination

Fungal-free survival at end of study drug therapy in infants with end-organ dissemination

Fungal-free survival was assessed by an independent data review panel (DRP). Fungal-free survival is defined as the percentage of participants alive one week after last dose of study drug with a mycological response of eradication based upon the DRP assessment and no requirement for alternative systemic antifungal therapy for continued treatment.

Fungal-free survival one week after last dose of study drug in infants with end-organ dissemination

An emergent fungal infection is defined as ● An invasive fungal infection which is detected at any time during the study that is a non-Candida organism, or ● An invasive fungal infection which is detected during the treatment or post-treatment period with a Candida species identified other than those detected at Baseline. If this occurred within 96 hours of the first dose of study drug, the infection was considered part of the final diagnosis of enrolling infection and not an emergent infection.

Percentage of participants with emergent fungal infections

A recurrent infection is defined as a systemic fungal infection in an infant with eradication at the end of study drug therapy, who developed positive blood cultures or a mycologically confirmed deep-seated Candida infection, with the same species as the enrolling infection.

Participants in the full analysis set with eradication at the end of study drug therapy.

Percentage of participants with recurrent fungal infections

Time to a positive clinical response is defined as the time from the first dose to the day during the treatment period that a positive clinical response (defined as a complete response or partial response) is observed for the first time, assessed by the Investigator. Complete Response is defined as the resolution of all attributable signs related to fungal infection, if present at baseline and Partial Response is defined as improvement in attributable signs related to the fungal infection, if present at baseline. Infants without positive responses and who survived were censored at one day post the end of treatment. Infants without positive responses who died before completing the treatment period, or were lost to follow-up during the treatment were censored at their death or last contact day.

Full analysis set participants with clinical signs and symptoms related to the fungal Infection at Baseline

Time to positive clinical response

Complete

Partial

Stable

Progression

Missing

Clinical response assessments were based on the following definitions and assessed by the DRP: ● Complete Response: Resolution of all attributable signs related to fungal infection, if present at baseline. ● Partial Response: Improvement in attributable signs related to the fungal infection, if present at baseline. ● Stabilization: Minor improvement or no change in attributable signs related to the fungal infection, if present at baseline, and infant continued on therapy without deterioration. ● Progression: Deterioration in attributable signs related to the fungal infection, if present at baseline; or if death occurred presumably related to a fungal infection.

Clinical response at the end of study drug therapy

Clinical response assessments were based on the following definitions and assessed by the DRP: • Complete Response: Resolution of all attributable signs related to fungal infection, if present at baseline. • Partial Response: Improvement in attributable signs related to the fungal infection, if present at baseline. • Stabilization: Minor improvement or no change in attributable signs related to the fungal infection, if present at baseline, and infant continued on therapy without deterioration. • Progression: Deterioration in attributable signs related to the fungal infection, if present at baseline; or if death occurred presumably related to a fungal infection.

Clinical response one week after last dose of study drug

Eradication

Persistence

Not Assessed

Mycological response assessments were based on the following definitions and assessed by the DRP: ● Eradication: Culture or histologically documented absence of the infecting Candida species from all positive normally sterile sites during therapy, documented by 2 negative samples, drawn at least 24 h apart; for Candida meningitis and/or candiduria, 1 negative culture. ● Persistence: Continued isolation or histological documentation from a normally sterile site.

Mycological response at end of study drug therapy

Continuing Eradication/Eradication

Mycological response assessments were based on the following definitions and assessed by the DRP: • Eradication: Culture or histologically documented absence of the infecting Candida species from all positive normally sterile sites during therapy, documented by 2 negative samples, drawn at least 24 h apart; for Candida meningitis and/or candiduria, 1 negative culture. • Persistence: Continued isolation or histological documentation from a normally sterile site.

Mycological response one week after last dose of study drug

Improved

Worsened

End-organ dissemination was assessed through abdominal ultrasound and/or computed tomography (CT), echocardiogram, head imaging and retinal exam. Each specific finding, documented by 1 of these techniques, was evaluated as follows: ● Improvement: Improvement in size, number or density of identified lesions. Complete response was not expected but may have been documented. ● Stabilization: Minor improvement or no change in size, number or density of identified lesions. ● Worsening: Increase in size or number of identified lesions.

Full analysis set participants with end-organ assessments

Follow-up status for infants with end-organ assessments

Within 15 Minutes Post IV

4-8 Hours Post IV

15-24 Hours Post IV

The pharmacokinetics (PK) analysis set, including those infants who received any amount of study drug, have at least one study drug concentration, and have dosing and blood collection date and time data sufficient for inclusion in a population pharmacokinetic analysis.

Plasma Micafungin Concentration

Overall Study

In total, 31 infants were screened and 30 were randomized in a 2:1 ratio to receive micafungin or amphotericin B deoxycholate. Randomization was stratified by estimated gestational age (< 27 weeks, ≥ 27 weeks) and by region (North America/Europe, Latin America / Mexico, other region).