Unique ID issued by UMIN | UMIN000006928 |
---|---|
Receipt number | R000008187 |
Scientific Title | Efficacy and safety of CH-001 in patients with chronic hepatitis C or NAFLD/NASH (placebo comparative study) |
Date of disclosure of the study information | 2011/12/21 |
Last modified on | 2013/01/23 17:40:42 |
Efficacy and safety of CH-001 in patients with chronic hepatitis C or NAFLD/NASH (placebo comparative study)
Use of CH-001 in HCV or NAFLD/NASH
Efficacy and safety of CH-001 in patients with chronic hepatitis C or NAFLD/NASH (placebo comparative study)
Use of CH-001 in HCV or NAFLD/NASH
Japan |
Chronic hepatitis C or NAFLD/NASH
Hepato-biliary-pancreatic medicine |
Others
NO
Electric therapy apparatus CH-001 or placebo is used in patients with chronic hepatitis C or NAFLD/NASH in a randomized, double-blind manner to evaluate effects on hepatic function and others.
Safety,Efficacy
ALT after 8-week treatment
Interventional
Parallel
Randomized
Double blind -all involved are blinded
Placebo
2
Treatment
Device,equipment |
Use of electric therapy apparatus CH-001 for 60 min/treatment, 3 times/day, 8 weeks.
Use of placebo for 60 min/treatment, 3 times/day, 8 weeks.
20 | years-old | <= |
Not applicable |
Male and Female
1) Patients with chronic hepatitis C or NAFLD/NASH and with/without cirrhosis
2) Serum ALT at screening: 61 iU/L and higher
[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
40
1st name | |
Middle name | |
Last name | Shuntaro Obi |
Kyoundo Hospital
Department of Hepatology
1-8, Surugadai, Kanda, Chiyoda-ku, Tokyo
1st name | |
Middle name | |
Last name |
Kyoundo Hospital
Department of Hepatology
1-8, Surugadai, Kanda, Chiyoda-ku, Tokyo
Kyoundo Hospital
None
Self funding
NO
2011 | Year | 12 | Month | 21 | Day |
Unpublished
Open public recruiting
2011 | Year | 10 | Month | 18 | Day |
2012 | Year | 01 | Month | 01 | Day |
2011 | Year | 12 | Month | 21 | Day |
2013 | Year | 01 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008187