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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000019296
Receipt No. R000022318
Scientific Title Phase 4 study of nalfurafine hydrochloride for pruritus in patients with PBC
Date of disclosure of the study information 2015/10/09
Last modified on 2018/02/05

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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
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
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
Co-sponsor
Name of secondary funder(s)

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
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2015 Year 09 Month 29 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 01 Day
Last follow-up date
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
2018 Year 02 Month 05 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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