UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029482 |
|---|---|
| Receipt number | R000033685 |
| Scientific Title | Study of combination immunosuppressive therapy in primary sclerosing cholangitis - A multicenter study for combination immunosuppressive therapy with mizoribine and azathioprine - |
| Date of disclosure of the study information | 2017/10/10 |
| Last modified on | 2020/10/12 11:01:20 |
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Basic information
Public title
Study of combination immunosuppressive therapy in primary sclerosing cholangitis - A multicenter study for combination immunosuppressive therapy with mizoribine and azathioprine -
Acronym
Study of combination immunosuppressive therapy in primary sclerosing cholangitis
Scientific Title
Study of combination immunosuppressive therapy in primary sclerosing cholangitis - A multicenter study for combination immunosuppressive therapy with mizoribine and azathioprine -
Scientific Title:Acronym
Study of combination immunosuppressive therapy in primary sclerosing cholangitis
Region
| Japan |
Condition
Condition
Primary sclerosing cholangitis
Classification by specialty
| Hepato-biliary-pancreatic medicine | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of combination immunosuppressive therapy with mizoribine and azathioprine in children with primary sclerosing cholangitis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Liver function (AST, ALT or gamma GTP, jaundice)
Key secondary outcomes
1.Hepatic histopathological evaluation
2.MRCP
3.Physical conditions
4.Incidence of adverse event and abnormal laboratory data
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of mizoribine and azathioprine
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with primary sclerosing cholangitis
2. Patients given written informed consent
Key exclusion criteria
1. Patients with some history of hypersensitivity to Bredini, Imuran, or Azanin Tablets
2. WBC:<=3000/mm3
3. Pregnants or patients who desire pregnancy
4. Patients with severe allergy
5. Patients who are judged inappropriate by the principal investigator
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Tajiri |
Organization
Osaka General Medical Center
Division name
Department of Pediatrics
Zip code
558-8558
Address
3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka
TEL
06-6692-1201
tajiriji@gh.opho.jp
Public contact
Name of contact person
| 1st name | Hitoshi |
| Middle name | |
| Last name | Tajiri |
Organization
Osaka General Medical Center
Division name
Department of Pediatrics
Zip code
558-8558
Address
3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka
TEL
06-6692-1201
Homepage URL
tajiriji@gh.opho.jp
Sponsor or person
Institute
Osaka General Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka General Medical Center
Address
3-1-56 Mandai-higash Sumiyoshi-ku Osaka
Tel
0666921201
kenkyusien@gh.opho.jp
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
大阪急性期・総合医療センター（大阪府）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
6
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
| 2011 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 10 | Day |
Last modified on
| 2020 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033685
| 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 |
