UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of the combination therapy of Juzen-taiho-to (TJ-48) and ursodeoxycholic acid (UDCA) in HCV-associated chronic liver disease: a prospective, randomized, cross-over study
Acronym	Efficacy of TJ-48 combined with UDCA in HCV-associated chronic liver disease
Scientific Title	Efficacy of the combination therapy of Juzen-taiho-to (TJ-48) and ursodeoxycholic acid (UDCA) in HCV-associated chronic liver disease: a prospective, randomized, cross-over study
Scientific Title:Acronym	Efficacy of TJ-48 combined with UDCA in HCV-associated chronic liver disease
Region	Japan

Condition
Condition	HCV-associated chronic liver disease
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine efficacy and safety of the combination therapy of TJ-48 and UDCA in HCV-associated chronic liver disease
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Improvement of serum alanine amino transferase levels after combination therapy of TJ-48 and UDCA for 16 weeks against UDCA alone therapy
Key secondary outcomes	1) Ratio of the patients who improved more than 25% in serum alanine amino transferase levels 2) Changes of liver function tests during the treatment 3) Adverse events

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	TJ-48 and UDCA (600 mg) are initially administered for 16 weeks, then UDCA is administered for the remaining 24 weeks.
Interventions/Control_2	UDCA is initaially administered for 16 weeks, then TJ-48 is combined for 16 weeks after the observational period for 8 weeks.
Interventions/Control_3
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Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	30 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	1) HCV-associated chronic hepatitis and liver cirrhosis * Diagnosis of liver cirrhosis is made histologically and/or clinically 2) Patients who has not been administered juzen-taiho-to 3) Patients who had been administrated UDCA for 24 or more weeks of UDCA 4) Patients who were ineffective of PEG-IFN therapy or not indicated of this therapy 5) ALT>=45,<120 6) Child-Pugh A 7) Age 30-80 years 8) Participant who gave written informed consent
Key exclusion criteria	1) Patient who received interferon treatment in previous 24 weeks 2) Patients who received medical Kampo preparations in previous 4 weeks 3) Patients who received the so-called "liver function improving drug" other than UDCA 4) Patients with hepatocellular carcinoma 5)Patients with serious complications 6) Woman in pregnancy or willing to get pregnant 7) Patients who are judged as inadequate for the study
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kazuo Tarao
Organization	Tarao gastroenterological clinic
Division name	Tarao gastroenterological clinic
Zip code
Address	3F,Taiyo-Bldg,2-58-6 Futamatagawa, Asahi-ku , Yokohama City, 241-0821, Japan
TEL	045-360-6501
Email	nrg18449@nifty.com

Public contact
Name of contact person	1st name Middle name Last name Katsuaki Tanaka
Organization	Yokohama City University Medical Center
Division name	Gastroenterological Center
Zip code
Address	4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL	045-261-5656
Homepage URL
Email	k_tanaka@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University Medical Center
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	JAPAN

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
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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	たらお内科・消化器科（神奈川県） 横浜市立大学附属市民総合医療センター（神奈川県） 聖マリアンナ医科大学横浜市西部病院（神奈川県） 恩賜財団済生会神奈川県病院（神奈川県） 国家公務員共済組合連合会横須賀共済病院（神奈川県） 平塚市民病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2013 Year 10 Month 03 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
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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	2013 Year 08 Month 29 Day
Date of IRB
Anticipated trial start date	2013 Year 10 Month 03 Day
Last follow-up date	2016 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 10 Month 03 Day
Last modified on	2016 Year 12 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013954

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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