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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000012865
Receipt No. R000015035
Scientific Title Ursodeoxycholic acid for polycystic liver disease
Date of disclosure of the study information 2014/03/01
Last modified on 2016/07/15

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Basic information
Public title Ursodeoxycholic acid for polycystic liver disease
Acronym UDCA for PLD
Scientific Title Ursodeoxycholic acid for polycystic liver disease
Scientific Title:Acronym UDCA for PLD
Region
Japan

Condition
Condition polycystic liver disease, polycystic kidney disease
Classification by specialty
Hepato-biliary-pancreatic medicine Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To Assess the effect of Ursodeoxycholic acid (UDCA) in patients with hepatobiliary enzyme abnormalities caused by enlarged polycystic liver.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes normalization of biliary enzymes, and decrease the rate of cyst progression.
Key secondary outcomes improvement of nutrition markers

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 UDCA 600mg/day
Interventions/Control_2 standard treatment
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria presence of abnormality of biliary enzyme caused by polycystic liver.
Key exclusion criteria Patients with jaundice (T-Bil>2.0mg/dL), complete obstruction of biliary ducts, or fulminant hepatitis.
Patients with severe pancrease disease, GB stone, or gastric ulcers.
Patients who received hepatic TAE within a year.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenmei Takaichi
Organization Toranomon Hospital
Division name Nephrology center
Zip code
Address 2-2-2, Toranomon, Minato-ku, Tokyo, Japan
TEL 03-3588-1111
Email takaichi-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Junichi Hoshino
Organization Toranomon Hospital
Division name Nephrology Center
Zip code
Address 2-2-2, Toranomon, Minato-ku, Tokyo, Japan
TEL 03-3588-1111
Homepage URL
Email hoshino@toranomon.gr.jp

Sponsor
Institute Nephrology Center, Toranomon Hospital
Institute
Department

Funding Source
Organization Self-funding
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
Address
Tel
Email

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 虎の門病院(東京都)、虎の門病院分院(神奈川県)

Other administrative information
Date of disclosure of the study information
2014 Year 03 Month 01 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
2014 Year 01 Month 17 Day
Date of IRB
Anticipated trial start date
2014 Year 06 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 01 Month 15 Day
Last modified on
2016 Year 07 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015035

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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