NCT01413360CompletedPhase 4
Phase 4 Study of High Dose Vitamin C in Chronic Hepatitis Patients
Seoul National University Hospital1 site in 1 country10 target enrollmentStarted: August 2011Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- The Change in Serum Alanine Aminotransferase Level From Baseline to 12 Weeks
Study Overview
Brief Summary
The investigators will evaluate the efficacy of high dose vitamin C in chronic hepatitis patients whose serum liver enzymes are elevated more than upper limit.
Detailed Description
The changes of laboratory findings including serum transaminase levels, serum albumin levels, Child-Pugh score, MELD score, and APRI score will be evaluated.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •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
Arms & Interventions
HD Vitamin C
Experimental
High dose vitamin C
Intervention: High dose vitamin C (Drug)
Outcomes
Primary Outcomes
The Change in Serum Alanine Aminotransferase Level From Baseline to 12 Weeks
Time Frame: Baseline and 12 weeks
Serum alanine aminotransferase (ALT) level after 12 weeks of high dose vitamin C administration and Baseline serum ALT level
Secondary Outcomes
- The Change in Serum Interleukin 22 Level From Baseline to 12 Weeks(Baseline and 12 weeks)
Investigators
Jung-Hwan Yoon
Professor
Seoul National University Hospital
Study Sites (1)
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