UMIN-CTR Clinical Trial

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	Obsterics 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
Email	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
Email	naitou@hama-med.ac.jp

Sponsor
Institute	Department of Hospital Pharmacy, Hamamatsu University School of Medicine
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	Ethics Committee of Hamamatsu University School of Medicine
Address	Handayama, Hamamatsu 431-3192
Tel	053-435-2111
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049336