UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015176 |
|---|---|
| Receipt number | R000008818 |
| Scientific Title | Study of the correlation between doses and blood concentration of Liposomal-Amphotericin B (L-AMB) in children |
| Date of disclosure of the study information | 2014/09/16 |
| Last modified on | 2015/03/16 16:58:29 |
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Basic information
Public title
Study of the correlation between doses and blood concentration of Liposomal-Amphotericin B (L-AMB) in children
Acronym
Study of the correlation between doses and blood concentration of Liposomal-Amphotericin B (L-AMB) in children
Scientific Title
Study of the correlation between doses and blood concentration of Liposomal-Amphotericin B (L-AMB) in children
Scientific Title:Acronym
Study of the correlation between doses and blood concentration of Liposomal-Amphotericin B (L-AMB) in children
Region
| Japan |
Condition
Condition
febrile neutropenia or cryptosporidiosis
Classification by specialty
| Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To analyze the association the administration dose of Liposomal-Amphotericin B and plasma concentration, and validate the effectiveness and adverse events of Liposomal-Amphotericin B therapy.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The association between administration dose of Liposomal-Amphotericin B and plasma concentration
The association between trough plasma concentration of Liposomal-Amphotericin B and renala function
Key secondary outcomes
The associaetion between trough plasma concentration of Liposomal-Amphotericin B and outcome
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 0 | years-old | <= |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
An inpatient with febrile neutropenia or cryptosporidiosis who need the Liposomal-Amphotericin B therapy.
The patients who gave a concent to participate in this study.
Key exclusion criteria
The patients who has an allergy of the Liposomal-Amphotericin B.
The patients who is administrating of other intravenous antifungal drugs.
The patients who is judged inadequate for this study by the doctor.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | MURAMATSU Hideki |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Pediatrics
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
052-744-2294
hideki-muramatsu@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | NARITA Atsushi |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Pediatrics
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
052-744-2294
Homepage URL
stanza-la-speranza@nifty.com
Sponsor or person
Institute
Department of Pediatrics, Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
a research grant
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
No patient registered in this study.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 03 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 15 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 15 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 15 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 15 | Day |
Other
Other related information
blood concentration of L-AMB
Management information
Registered date
| 2014 | Year | 09 | Month | 16 | Day |
Last modified on
| 2015 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008818
