UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006664 |
|---|---|
| Receipt number | R000007856 |
| Scientific Title | Investigation of serum level of antituberculous and genetic polymorphism in NAT2 gene in patinet with pulmonary tuberculosis |
| Date of disclosure of the study information | 2011/11/03 |
| Last modified on | 2012/12/30 20:07:25 |
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Basic information
Public title
Investigation of serum level of antituberculous and genetic polymorphism in NAT2 gene in patinet with pulmonary tuberculosis
Acronym
Investigation of serum level of antituberculous and genetic polymorphism in NAT2 gene in patinet with pulmonary tuberculosis
Scientific Title
Investigation of serum level of antituberculous and genetic polymorphism in NAT2 gene in patinet with pulmonary tuberculosis
Scientific Title:Acronym
Investigation of serum level of antituberculous and genetic polymorphism in NAT2 gene in patinet with pulmonary tuberculosis
Region
| Japan |
Condition
Condition
pulmonary tuberculosis
Classification by specialty
| Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The objective of the investigation is to determine appropriate dose of antituberculous drug in Japanese patient of pulmonary tuberculosis related to NAT2 and interferon-gamma gene polymorphism.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Duration until acid-fast bacillus sputum examination converts to negative among objective patients.
Key secondary outcomes
The frequency and severity of adverse effects due to anti-tuberculous drugs among objective patinets
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The objectives in this investigation is those who fullfil the criterion below.
1) Patinet with active tuberulosis treated with antituberculous drug including rifampicin and isoniazid in Fukushima Medical University
2) Patient who agree written informed consent.
Key exclusion criteria
1) Patinet with drug resistant tuberculosis.
2) Patinet with Human Immunodeficiency virus
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kengo Oshima |
Organization
Fukushima Medical University
Division name
Department of pulmonary medicine
Zip code
Address
1Hikarigaoka, Fukusghima-city, Fukushima prefecture
TEL
024-547-1360
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kengo Oshima |
Organization
Fukushima Medical University
Division name
Department of pulmonary medicine
Zip code
Address
1Hikarigaoka, Fukusghima-city, Fukushima prefecture
TEL
024-547-1360
Homepage URL
Sponsor or person
Institute
Fukushima Medeical University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
福島県立医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 11 | Month | 03 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 11 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 05 | Month | 01 | Day |
Other
Other related information
We investigate serum concentration of rifampicin and isoniazid in patient with pulmonary tuberculosis who admit to Fukushima Medical University Hospital. The time of investigation is from 7 to 10 days after starting administration and 2 hours after oral administaration when shows maximum concentration in both drugs. We extract DNA from peripheral mononuclear cells obtained from objective patients and examine genetic polymorphism about NAT2 and interferon-gammma gene, and investigate association between polymorphism and serum concentration.
Clinical data of objective patients below are recorded.
1) age, sex, tall, body weight
2) past history (especially operation of digestive tract system)
3) renal function
4) liver function
5) concomitant drug
Management information
Registered date
| 2011 | Year | 11 | Month | 03 | Day |
Last modified on
| 2012 | Year | 12 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007856
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
