UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008069 |
|---|---|
| Receipt number | 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 21:00:03 |
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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
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
jintakajj@gmail.com
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
