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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000008069
Receipt No. R000009505
Scientific Title Study on reintroduction regimen of antituberculous therapy after developing of drug-induced hepatotoxicity (DIH)
Date of disclosure of the study information 2012/05/31
Last modified on 2019/03/27

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Basic information
Public title Study on reintroduction regimen of antituberculous therapy after developing of drug-induced hepatotoxicity (DIH)
Acronym Study on reintroduction regimen of antituberculous therapy after developing of drug-induced hepatotoxicity (DIH)
Scientific Title Study on reintroduction regimen of antituberculous therapy after developing of drug-induced hepatotoxicity (DIH)
Scientific Title:Acronym Study on reintroduction regimen of antituberculous therapy after developing of drug-induced hepatotoxicity (DIH)
Region
Japan

Condition
Condition tuberculosis
Classification by specialty
Pneumology Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the safety of reintroduction of antituberculous drugs especially pyrazinamide after developing drug-induced hepatotoxicity (DIH)
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Rate of safe reintroduction of PZA after INH/RFP re-administration for patients who developed DIH during initial standard antituberculous therapy
Key secondary outcomes Days of onset of DIH after starting initial standard therapy
Days of recovery after stopping initial standard therapy
Days of recurrence of DIH after readministration

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 patients who developed DIH during initial standard antituberculous therapy
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
85 years-old >
Gender Male and Female
Key inclusion criteria 1)Confirmed of active tuberculosis
2)Any nationalities
3)Patients who were initially treated with standard 4 drugs regimens for antituberculosis, developed DIH, and stopped of all antitubercuous drugs during intensive phase
4)written informed consent
Key exclusion criteria 1)HIV infection
2)Pregnancy of breast-feeding
3)Liver cirrhosis
4)Acute or chronic hepatitis infection
5)Known resistance against INH or RFP
6)Persistent liver damage
7)Abnormal laboratory finding; WBC <2,000/mm3, Hgb <7g/dL, Platelet count <50,000/mm3
8)Patients whom the attending physician decided unsuitable for entering the present study
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jin TAKASAKI
Organization National Center for Global Health and Medicine
Division name Respiratory Medicine
Zip code
Address 1-21-1, Toyama, Shinuku-Ku, Tokyo, Japan
TEL 03-3202-7181
Email jintakajj@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Jin TAKASAKI
Organization National Center for Global Health and Medicine
Division name Respiratory Medicine
Zip code
Address 1-21-1, Toyama, Shinuku-Ku, Tokyo, Japan
TEL 03-3202-7181
Homepage URL
Email jintakajj@gmail.com

Sponsor
Institute National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization National Center for Global Health and Medicine
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
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 国立国際医療研究センター

Other administrative information
Date of disclosure of the study information
2012 Year 05 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 Terminated
Date of protocol fixation
2012 Year 05 Month 31 Day
Date of IRB
2012 Year 05 Month 01 Day
Anticipated trial start date
2012 Year 05 Month 01 Day
Last follow-up date
2015 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 05 Month 31 Day
Last modified on
2019 Year 03 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009505

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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