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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000029482
Receipt No. 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 2020/04/15

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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
Email 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
Email tajiriji@gh.opho.jp

Sponsor
Institute Osaka General Medical Center
Institute
Department

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
Email 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
2021 Year 12 Month 09 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 10 Month 10 Day
Last modified on
2020 Year 04 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033685

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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