UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045425 |
|---|---|
| Receipt number | R000051865 |
| Scientific Title | Pharmacokinetics and efficacy of Vedolizumab in inflammatory bowel diseases |
| Date of disclosure of the study information | 2021/09/08 |
| Last modified on | 2021/09/08 21:38:32 |
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Basic information
Public title
Pharmacokinetics and efficacy of Vedolizumab in inflammatory bowel diseases
Acronym
Pharmacokinetics of Vedolizumab in inflammatory bowel diseases
Scientific Title
Pharmacokinetics and efficacy of Vedolizumab in inflammatory bowel diseases
Scientific Title:Acronym
Pharmacokinetics of Vedolizumab in inflammatory bowel diseases
Region
| Japan |
Condition
Condition
ulcerative colitis and Crohn's disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In inflammatory bowel disease patients, measure the serum level of vedolizumab, anti-vedolizumab antibody, and evaluate short-term and long-term efficacy and safety .In inflammatory bowel disease patients, measure the serum level of vedolizumab, anti-vedolizumab antibody, and evaluate short-term and long-term efficacy and safety .
We also examine the relationship between serum levels of vedolizumab and anti-vedolizumab antibody with patient background, treatment history and concomitant drug.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical remission at 30 weeks from the start of administration
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
inflammatory bowel disease patient being treated with vedolizumab or scheduled for treatment with vedolizumab
Key exclusion criteria
none
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Ohno |
Organization
Shiga University of Medical Science
Division name
Division of gastroenterology
Zip code
520-2192
Address
tukinowa-cho, otsu-shi, shiga, Japan
TEL
077-548-2111
hqmed2@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Imai |
Organization
Shiga University of Medical Science
Division name
Division of gastroenterology
Zip code
520-2192
Address
tukinowa-cho, otsu-shi, shiga, Japan
TEL
077-548-2111
Homepage URL
hqmed2@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Shiga University of Medical Science
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
Shiga University of Medical Science
Address
tukinowa-cho, otsu-shi, shiga, Japan
Tel
077-548-3576
hqrec@belle.shiga-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
| 2021 | Year | 09 | Month | 08 | 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
Suspended
Date of protocol fixation
| 2020 | Year | 01 | Month | 14 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 14 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 14 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2021 | Year | 09 | Month | 08 | Day |
Last modified on
| 2021 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051865
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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