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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT01413360 |
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Date of registration:
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09/08/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Effect of High Dose Vitamin C on the Liver Function in Chronic Hepatitis Patients
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Scientific title:
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Phase 4 Study of High Dose Vitamin C in Chronic Hepatitis Patients |
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Date of first enrolment:
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August 2011 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01413360 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 4
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Jung-Hwan Yoon, M.D, Ph.D |
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Address:
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Telephone:
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Email:
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Affiliation:
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Seoul National University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Chronic hepatitis C patients
- positive anti-HCV antibody more than 6 months
- serum alanine aminotransferase 40 - 80 IU/L for more than 6 months
- not indicated for antiviral therapy with interferon and ribavirin
2. Chronic alcoholic hepatitis
- significant alcohol drinking history and no other cause of chronic hepatitis
- serum alanine aminotransferase 40 - 80 IU/L for more than 6 months
Exclusion Criteria:
- Chronic hepatitis B, autoimmune hepatitis, primary biliary cirrhosis, Wilson's
disease, hemochromatosis, other chronic hepatitis except chronic hepatitis C or
alcoholic hepatitis
- decompensated liver cirrhosis
- platelet < 50,000/uL or white blood cell < 1,500/uL
- need and willing for antiviral therapy
- significant renal dysfunction (GFR < 30 mL/min/kg) or history of renal stone
- hepatotonic drug (i.e. silymarin, garlic oil, aronamin gold) usage within 2 weeks
- pregnancy, lactating woman
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Chronic Hepatitis
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Chronic Hepatitis C
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Chronic Alcoholic Hepatitis
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Intervention(s)
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Drug: High dose vitamin C
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Primary Outcome(s)
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The Change in Serum Alanine Aminotransferase Level From Baseline to 12 Weeks
[Time Frame: Baseline and 12 weeks]
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Secondary Outcome(s)
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The Change in Serum Interleukin 22 Level From Baseline to 12 Weeks
[Time Frame: Baseline and 12 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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