UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048070 |
|---|---|
| Receipt number | R000054693 |
| Scientific Title | Efficacy and safety of Janus kinase 1 inhibitor for chronic pouchitis in patients with ulcerative colitis |
| Date of disclosure of the study information | 2022/07/01 |
| Last modified on | 2022/06/16 09:05:18 |
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Basic information
Public title
Efficacy and safety of filgotinib for refractory pouchitis in patients with ulcerative colitis
Acronym
Efficacy of filgotinib for pouchitis
Scientific Title
Efficacy and safety of Janus kinase 1 inhibitor for chronic pouchitis in patients with ulcerative colitis
Scientific Title:Acronym
Efficacy of Janus kinase 1 inhibitor for pouchitis
Region
| Japan |
Condition
Condition
ulcerative colitis, pouchitis
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of filgochinib for pouchitis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
imprpvement by using modified pouchitis activity index with treatment.(Evaluations will be performed after 12weeks and 54 weeks of induction.
Key secondary outcomes
Incidence and kinds of adverse events during treatment.
Secession from antibiotics use.
Alteration of antibiotics dosage.
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
Treatment with filgochinib
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Anti-biotics dependent or refractory pouchitis.
Key exclusion criteria
Patients who dose not agree the treatment with filgochinib.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Ikeuchi |
Organization
Hyogo medical university
Division name
Department of Gastroenterological surgery
Zip code
6638501
Address
1-1 Mukogawacho, Nshinomiya city, Hyogo pref
TEL
0798456371
ikeuci2s@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Motoi |
| Middle name | |
| Last name | Uchino |
Organization
Hyogo medical university
Division name
Department of Gastroenterological surgery
Zip code
6638501
Address
1-1 Mukogawacho, Nshinomiya city, Hyogo pref
TEL
0798456371
Homepage URL
uchino2s@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo medical university
Department of Gastroenterological Surgery
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterological Surgery,
Hyogo Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo medical university
Address
1-1 Mukogawacho, Nishinomiya, Hyogo
Tel
0798456371
uchino2s@hyo-med.ac.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2022 | Year | 06 | Month | 16 | Day |
Last modified on
| 2022 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054693
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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