Unique ID issued by UMIN | UMIN000011948 |
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Receipt number | 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 09:51:24 |
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
Efficacy of TJ-48 combined with UDCA in HCV-associated chronic liver disease
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
Efficacy of TJ-48 combined with UDCA in HCV-associated chronic liver disease
Japan |
HCV-associated chronic liver disease
Hepato-biliary-pancreatic medicine |
Others
NO
To examine efficacy and safety of the combination therapy of TJ-48 and UDCA in HCV-associated chronic liver disease
Safety,Efficacy
Confirmatory
Pragmatic
Phase II
Improvement of serum alanine amino transferase levels after combination therapy of TJ-48 and UDCA for 16 weeks against UDCA alone therapy
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
Interventional
Cross-over
Randomized
Individual
Open -no one is blinded
Active
NO
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Treatment
Medicine |
TJ-48 and UDCA (600 mg) are initially administered for 16 weeks, then UDCA is administered for the remaining 24 weeks.
UDCA is initaially administered for 16 weeks, then TJ-48 is combined for 16 weeks after the observational period for 8 weeks.
30 | years-old | <= |
80 | years-old | > |
Male and Female
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
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
60
1st name | |
Middle name | |
Last name | Kazuo Tarao |
Tarao gastroenterological clinic
Tarao gastroenterological clinic
3F,Taiyo-Bldg,2-58-6 Futamatagawa, Asahi-ku , Yokohama City, 241-0821, Japan
045-360-6501
nrg18449@nifty.com
1st name | |
Middle name | |
Last name | Katsuaki Tanaka |
Yokohama City University Medical Center
Gastroenterological Center
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
045-261-5656
k_tanaka@yokohama-cu.ac.jp
Yokohama City University Medical Center
None
Self funding
JAPAN
NO
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)
2013 | Year | 10 | Month | 03 | Day |
Unpublished
Completed
2013 | Year | 08 | Month | 29 | Day |
2013 | Year | 10 | Month | 03 | Day |
2016 | Year | 12 | Month | 31 | Day |
2013 | Year | 10 | Month | 03 | Day |
2016 | Year | 12 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013954
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