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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011948
Receipt No. R000013954
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
Date of disclosure of the study information 2013/10/03
Last modified on 2016/12/16

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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
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
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)
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 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
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
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
Registered date File name

Research case data
Registered date File name


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