UMIN-CTR Clinical Trial

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

HCV-associated chronic liver disease

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

Yokohama City University Medical Center

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

JAPAN

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2013

Year

10

Month

03

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2013

Year

10

Month

03

Day

Last modified on

2016

Year

12

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013954