UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043232 |
|---|---|
| Receipt number | R000049336 |
| Scientific Title | Elucidation of the mechanism of changes in plasma thyroxine levels based on quantitative evaluation of OATP1B transport activity during pregnancy |
| Date of disclosure of the study information | 2021/02/02 |
| Last modified on | 2021/02/02 19:29:02 |
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Basic information
Public title
Elucidation of the mechanism of changes in plasma thyroxine levels based on quantitative evaluation of OATP1B transport activity during pregnancy
Acronym
Changes in plasma thyroxine levels during pregnancy
Scientific Title
Elucidation of the mechanism of changes in plasma thyroxine levels based on quantitative evaluation of OATP1B transport activity during pregnancy
Scientific Title:Acronym
Changes in plasma thyroxine levels during pregnancy
Region
| Japan |
Condition
Condition
Pregnant women
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The aim of this study is to explore mechanisms of changes in thyroxin levels during pregnancy.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The plasma concentrations of OATP1B biomarkers during pregnancy
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1. Perinatal women
2. Patients from whom written informed consent was obtained
Key exclusion criteria
1.Patients assessed as inappropriate for the study enrollment by the attending physician
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Junichi |
| Middle name | |
| Last name | Kawakami |
Organization
Hamamatsu University School of Medicine
Division name
Department of Hospital pharmacy
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka
TEL
053-435-2763
pharmacyham-adm@umin.ac.jp
Public contact
Name of contact person
| 1st name | Takafumi |
| Middle name | |
| Last name | Naito |
Organization
Hamamatsu University School of Medicine
Division name
Department of Hospital pharmacy
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka
TEL
053-435-2763
Homepage URL
naitou@hama-med.ac.jp
Sponsor or person
Institute
Department of Hospital Pharmacy, Hamamatsu University School of Medicine
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
Ethics Committee of Hamamatsu University School of Medicine
Address
Handayama, Hamamatsu 431-3192
Tel
053-435-2111
rinri@hama-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
浜松医科大学医学部附属病院（静岡県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 02 | Month | 02 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 12 | Month | 09 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 11 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 09 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: Observational study
Object recruitment: Perinatal women who visit our hospital from December 2019 to November 2024
Primary outcome:
1. Evaluation of activity of OATP1B transport based on validation of OATP1B biomarkers
2. Measurement of plasma thyroxine
Secondary outcome:
1. Pathology
2. Patient characteristics
3. Concomitant drug
4.Laboratory values, hormones related to pregnancy
5.Genetic variants of OATP1B
6.Micro RNA related to OATP1B activity
7.Metabolic enzymes related to activation of thyroid hormones
8.Vital sign
9. Adverse effects
Management information
Registered date
| 2021 | Year | 02 | Month | 02 | Day |
Last modified on
| 2021 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049336
