UMIN-CTR Clinical Trial
| 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 |
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Basic information
Public title
Efficacy and safety of CH-001 in patients with chronic hepatitis C or NAFLD/NASH (placebo comparative study)
Acronym
Use of CH-001 in HCV or NAFLD/NASH
Scientific Title
Efficacy and safety of CH-001 in patients with chronic hepatitis C or NAFLD/NASH (placebo comparative study)
Scientific Title:Acronym
Use of CH-001 in HCV or NAFLD/NASH
Region
| Japan |
Condition
Condition
Chronic hepatitis C or NAFLD/NASH
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
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.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ALT after 8-week treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Use of electric therapy apparatus CH-001 for 60 min/treatment, 3 times/day, 8 weeks.
Interventions/Control_2
Use of placebo for 60 min/treatment, 3 times/day, 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
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with chronic hepatitis C or NAFLD/NASH and with/without cirrhosis
2) Serum ALT at screening: 61 iU/L and higher
Key exclusion criteria
[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
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuntaro Obi |
Organization
Kyoundo Hospital
Division name
Department of Hepatology
Zip code
Address
1-8, Surugadai, Kanda, Chiyoda-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kyoundo Hospital
Division name
Department of Hepatology
Zip code
Address
1-8, Surugadai, Kanda, Chiyoda-ku, Tokyo
TEL
Homepage URL
Sponsor or person
Institute
Kyoundo Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 12 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
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
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2011 | Year | 10 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 12 | Month | 21 | Day |
Last modified on
| 2013 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008187
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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