UMIN-CTR Clinical Trial

Basic information
Public title	Phase 4 study of nalfurafine hydrochloride for pruritus in patients with PBC
Acronym	Nalfurafine for pruritus in PBC
Scientific Title	Phase 4 study of nalfurafine hydrochloride for pruritus in patients with PBC
Scientific Title:Acronym	Nalfurafine for pruritus in PBC
Region	Japan

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

Objectives
Narrative objectives1	Primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC) is a chronic cholestatic disease, and patients with chronic cholestatic diseases frequently suffer from pruritus. Nalfurafine chloride is an k-receptor agonist and was approved for improvement of pruritus of patients with chronic cholestatic diseases in May 2015. In this study we aim to examine efficacy of nalfurafine chloride for patients with chronic cholestatic diseases as phase 4 study.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	improvement of pruritus and quality of life at 3 months after nalfurafine administration. Pruritus and QOL will be judged by PBC-40.
Key secondary outcomes	liver function tests, 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
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Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with PBC or PSC, who were indicated for nalfurafine treatment by physician.
Key exclusion criteria	patients with a history of allergy to nalfurafine, patients with severe liver impairment (Child-Pugh grade C), patients with mild pruritus, and patients who were not indicated for nalfurafine treatment.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Middle name Last name Atsushi Tanaka
Organization	Teikyo University School of Medicine
Division name	Department of Medicine
Zip code
Address	2-11-1, Kaga, Itabashi-ku, Tokyo
TEL	03-3064-1211
Email	a-tanaka@med.teikyo-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Atsushi Tanaka
Organization	Teikyo University School of Medicine
Division name	Department of Medicine
Zip code
Address	2-11-1, Kaga, Itabashi-ku, Tokyo
TEL	03-3064-1211
Homepage URL
Email	a-tanaka@med.teikyo-u.ac.jp

Sponsor
Institute	Teikyo University School of Medicine
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research for Developmenet
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
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IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	YES
Study ID_1	NCT02659696
Org. issuing International ID_1	clinicaltrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2015 Year 10 Month 09 Day

Related information
URL releasing protocol
Publication of results	Partially published

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
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Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 09 Month 29 Day
Date of IRB	2015 Year 10 Month 01 Day
Anticipated trial start date	2015 Year 10 Month 01 Day
Last follow-up date	2017 Year 12 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 or PSC who met inclusion criteria visiting each participating facility from the beginning of the study until 2017/3/31 Measurements: PBC-40 scores, blood chemistries, and serum autaxin level at baseline and after nalfurafine administration

Management information
Registered date	2015 Year 10 Month 09 Day
Last modified on	2020 Year 03 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022318