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Clinical Trials/NCT01413360
NCT01413360
Completed
Phase 4

Phase 4 Study of High Dose Vitamin C in Chronic Hepatitis Patients

Seoul National University Hospital1 site in 1 country10 target enrollmentAugust 2011
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ConditionsChronic HepatitisChronic Hepatitis CChronic Alcoholic Hepatitis
InterventionsHigh dose vitamin C
DrugsHigh dose vitamin C

Overview

Phase
Phase 4
Intervention
High dose vitamin C
Conditions
Chronic Hepatitis
Sponsor
Seoul National University Hospital
Enrollment
10
Locations
1
Primary Endpoint
The Change in Serum Alanine Aminotransferase Level From Baseline to 12 Weeks
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

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.

Registry
clinicaltrials.gov
Start Date
August 2011
End Date
December 2014
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jung-Hwan Yoon

Professor

Seoul National University Hospital

Eligibility Criteria

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

High dose vitamin C

Intervention: High dose vitamin C

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)

Study Sites (1)

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