HCV-associated chronic liver disease
Conditions
Interventions
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
Sponsors
Yokohama City University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of serum alanine amino transferase levels after combination therapy of TJ-48 and UDCA for 16 weeks against UDCA alone therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactKatsuaki Tanaka
Yokohama City University Medical Center Gastroenterological Center
Outcome results
None listed