UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020406 |
|---|---|
| Receipt number | R000023244 |
| Scientific Title | Study for personalized medicine based on pharmacokinetics and pharmacodynamics concerned with therapeutic drug of nontuberculous mycobacterium. |
| Date of disclosure of the study information | 2015/12/31 |
| Last modified on | 2017/10/25 20:52:23 |
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Basic information
Public title
Study for personalized medicine based on pharmacokinetics and pharmacodynamics concerned with therapeutic drug of nontuberculous mycobacterium.
Acronym
Study of NTM PK/PD
Scientific Title
Study for personalized medicine based on pharmacokinetics and pharmacodynamics concerned with therapeutic drug of nontuberculous mycobacterium.
Scientific Title:Acronym
Study of NTM PK/PD
Region
| Japan |
Condition
Condition
patients administered with therapeutic drug of nontuberculous mycobacterium
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Study for personalized medicine based on pharmacokinetics and pharmacodynamics concerned with therapeutic drug of nontuberculous mycobacterium
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Study for personalized medicine with therapeutic drug of nontuberculous mycobacterium
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients who were given EB, CAM, RFP judged that administration was necessary by a chief physician
Key exclusion criteria
(1) It is the patient with a history of the drug allergy in EB, CAM, RFP
(2) HIV infection therapeutic drug (indinavir sulfate ethanol addition, saquinavir mesilate, nelfinavir mesilate,
L biTaegu rabbi a type of radical preparation including), voriconazole, praziquantel, Tadalafil, terra pre-building, Japanese hawfinch pre-building sodium, pimozide, ergotamine component preparation, the patients receiving etc.,
(3) In the patients with impaired liver or kidney, it is the patient receiving the colchicine
(4) The patients with biliary tract obstruction or the serious liver damage
(5) Optic neuritis, patients with diabetes, patients with alcoholism
(6) For an infection related to this medicine insusceptibility pathogen or resistant strain, it is the patient who is judged clinically when it is hard to expect an effect with this medicine
(7) Pregnant woman, the patients nursing, the patients who may be pregnant
(8) In addition, the patients who judged that it was inadequate as an object of this study
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Hasegawa |
Organization
Center for Infectious Diseases and Infection Control
Keio University Hospital
Division name
Center for Infectious Diseases and Infection Control
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
0333531211
osamu.iketani@adst.keio.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Osamu Iketani |
Organization
Center for Infectious Disease and Infection Control
Division name
Center for Infectious Disease and Infection Control
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
0333531211
Homepage URL
osamu.iketani@adst.keio.ac.jp
Sponsor or person
Institute
Center for Infectious Disease and Infection Control
Institute
Department
Personal name
Funding Source
Organization
Center for Infectious Disease and Infection Control
Organization
Division
Category of Funding Organization
Other
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
| 2015 | Year | 12 | Month | 31 | 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
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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 12 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 09 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study for personalized medicine based on pharmacokinetics and pharmacodynamics concerned with therapeutic drug of nontuberculous mycobacterium
Management information
Registered date
| 2015 | Year | 12 | Month | 30 | Day |
Last modified on
| 2017 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023244
