UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000006664
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email

Sponsor
Institute Fukushima Medeical University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007856

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.