UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019296 |
|---|---|
| Receipt number | 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 | 2020/03/19 18:26:14 |
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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
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
a-tanaka@med.teikyo-u.ac.jp
Sponsor or person
Institute
Teikyo University School of Medicine
Institute
Department
Personal name
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022318
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
