UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030743 |
|---|---|
| Receipt number | R000035110 |
| Scientific Title | Efficacy and Safety of Tacrolimus as Secondline Therapy for Patients With Autoimmune Hepatitis Pilot Study |
| Date of disclosure of the study information | 2018/01/15 |
| Last modified on | 2021/01/21 17:33:04 |
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Basic information
Public title
Efficacy and Safety of Tacrolimus as Secondline Therapy for Patients With Autoimmune Hepatitis Pilot Study
Acronym
Efficacy and Safety of Tacrolimus as Secondline Therapy for Patients With Autoimmune Hepatitis
Scientific Title
Efficacy and Safety of Tacrolimus as Secondline Therapy for Patients With Autoimmune Hepatitis Pilot Study
Scientific Title:Acronym
Efficacy and Safety of Tacrolimus as Secondline Therapy for Patients With Autoimmune Hepatitis
Region
| Japan |
Condition
Condition
Autoimmune Hepatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Predniso(lo)ne, alone or in combination with azathioprine, is the standard-of-care (SOC) therapy for autoimmune hepatitis (AIH). However, the SOC therapy is poorly tolerated or does not control disease activity in up to 20% of patients. We assessed the efficacy of mycophenolate tacrolimus as second-line therapy for patients with AIH.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of patients who had normal ALT at 2 weeks from initial tacrolimus treatment
The duration which had normal ALT at 2 weeks from initial tacrolimus treatment
The rate of patients who had normal IgG at 2 weeks from initial tacrolimus treatment
The duration which had normal IgG at 2 weeks from initial tacrolimus treatment
The rate of patients who had normal ALT at 2 years from initial tacrolimus treatment
The rate of patients who had normal IgG at 2 years from initial tacrolimus treatment
Safety
Key secondary outcomes
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
Tacrolimus
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients who had diagnosis of Autoimmune Hepatitis by guideline of 2013
2) Patients is poorly tolerated by Predniso(lo)ne, alone or in combination with azathioprine
3 Patients who can not treated with azathioprine due to adverse event
Key exclusion criteria
1. Liver cirrhosis
2. HBV , HCV, PBC, NASH
3. Arrergy of Tacrolimus
4. Arrergy of ciclosporin
5. Patents who treated with potassium-conserving diuretic
6. Pregnancy
7. Patients who hope of pregnancy
8. Severe infection
9. Patients who judge exclusion criteria by doctor
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuaki Chayama |
Organization
Hiroshima University Hospital
Division name
Department of Gastroenterology and Metabolism
Zip code
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
TEL
082-257-5555
chayama@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomokazu Kawaoka |
Organization
Hiroshima University Hospital
Division name
Department of Gastroenterology and Metabolism
Zip code
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
TEL
082-257-5555
Homepage URL
kawaokatomo@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 15 | 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
| 2017 | Year | 12 | Month | 28 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2022 | 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
| 2018 | Year | 01 | Month | 10 | Day |
Last modified on
| 2021 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035110
