Efficacy and safety of CH-001 in patients with chronic hepatitis C or NAFLD/NASH (placebo comparative study)
- Conditions
- Chronic hepatitis C or NAFLD/NASH
- Registration Number
- JPRN-UMIN000006928
- Lead Sponsor
- Kyoundo Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Not provided
[All subjects] 1) Decompensated cirrhosis 2) Other hepatitis virus infections 3) HIV positive 4) Serious chronic bacterial infections 5) Malignant tumour 6) Autoimmune hepatic disorders 7) Alcoholic hepatic disorders or daily alcoholic intake of more than 20g/day 8) Drug-induced hepatic disorders 9) Fulminant hepatitis 10) Biliary disorders 11) Cardiac, renal, or spleen complications requiring hospitalized therapy 12) Sensory disorders due to severe peripheral circulatory disorders 13) During pregnancy/breast feeding, presenting signs of pregnancy, or planning to be pregnant 14) Anti-oxidative therapy within 4 weeks before screening 15) Implantable medical electronics (MEs), life-sustaining MEs, or body-worn MEs [HepC] 1) Interferon and/or ribavirin therapy within 26 weeks before screening 2) Therapy with choleretics, glycyrrhizin compounds, or others within 4 weeks before screening [NAFLD/NASH] 1) Start of therapy with insulin sensitizers, lipid lowering drugs, or others within 4 weeks before screening 2) Start of dietary and/or exercise therapy within 4 weeks before screening 3) Surgical treatments for severe obesity within 4 weeks before screening
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ALT after 8-week treatment
- Secondary Outcome Measures
Name Time Method