UMIN-CTR Clinical Trial

Basic information
Public title	Predictive factors of efficacy of Nalfurafine hydrochloride for pruritus in patients with PBC
Acronym	Predictive factors of Nalfurafine treatment in PBC with pruritus
Scientific Title	Predictive factors of efficacy of Nalfurafine hydrochloride for pruritus in patients with PBC
Scientific Title:Acronym	Predictive factors of Nalfurafine treatment in PBC with pruritus
Region	Japan

Condition
Condition	primary biliary cholangitis
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In this study we aim to examine efficacy of nalfurafine chloride for patients with primary biliary cholangitis and to identify predictive factors of nalfurafine hydrochloride efficacy for pruritus.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	Improvement of pruritus at 8 weeks after nalfurafine administration.
Key secondary outcomes	blood biochemistry, serum autaxin levels

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	85 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with PBC, who were indicated for nalfurafine treatment by physician.
Key exclusion criteria	Patients with pregnancy, patients with malignancy, patients with a history of allergy to nalfurafine, patients with severe liver impairment (Child-Pugh grade C), and patients who were not indicated for nalfurafine treatment.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Yasuhiro Middle name Last name Takikawa
Organization	Iwate Medical University
Division name	Division of Hepatology, Department of Internal medicine
Zip code	0208505
Address	19-1, Uchimaru, Morioka, Japan
TEL	019-651-5111
Email	ytakikaw@iwate-med.ac.jp

Public contact
Name of contact person	1st name Keisuke Middle name Last name Kakisaka
Organization	Iwate Medical University
Division name	Division of Hepatology, Department of Internal medicine
Zip code	0208505
Address	19-1, Uchimaru, Morioka, Japan
TEL	019-651-5111
Homepage URL
Email	keikaki@iwate-med.ac.jp

Sponsor
Institute	Iwate Medical University
Institute
Department

Funding Source
Organization	Iwate Medical University
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	Iwate Medical University
Address	Uchimaru 19-1, Morioka
Tel	0196515111
Email	yoshiday@iwate-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	岩手医科大学附属病院（岩手県）

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 11 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	Completed
Date of protocol fixation	2016 Year 01 Month 27 Day
Date of IRB	2016 Year 02 Month 04 Day
Anticipated trial start date	2016 Year 04 Month 11 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Design: open-label, prospective cohort study Recruitment: all patients with PBC who met inclusion criteria from the beginning of the study until 2017/1/30 Measurements: visual analog scale for pruritus, blood chemistries, and serum autaxin level at baseline and after nalfurafine administration

Management information
Registered date	2016 Year 03 Month 30 Day
Last modified on	2020 Year 06 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025006