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A Pilot Study of High-Dose, Intravenous Ascorbic Acid (Vitamin C) to Treat Hepatitis C

This study has been terminated.
Sponsor:
Information provided by:
Health Innovations, Frontier Research Institute
ClinicalTrials.gov Identifier:
NCT01250743
First received: November 29, 2010
Last updated: February 17, 2011
Last verified: November 2010

November 29, 2010
February 17, 2011
January 2009
December 2011   (final data collection date for primary outcome measure)
number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
clinical and/or laboratory adverse events
number of participants with adverse events as a measure of safety and tolerability [ Time Frame: during 5 months of treatment and 1 month of follow up off treatment ] [ Designated as safety issue: Yes ]
clinical and/or laboratory adverse events
Complete list of historical versions of study NCT01250743 on ClinicalTrials.gov Archive Site
  • anti-viral efficacy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    measured by reduction of circulating hepatitis C viral levels
  • aspartate aminotransferase (AST or SGOT) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    reduced circulating levels of AST (or SGOT), as a measure of liver inflammation
  • alanine aminotransferase (ALT or SGPT) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    reduced circulating levels of ALT (or SGPT), as a measure of liver inflammation
anti-viral efficacy [ Time Frame: during 5 months of treatment and 1 month of follow up off treatment ] [ Designated as safety issue: No ]
measured by reduction of circulating hepatitis C viral levels
Not Provided
Not Provided
 
A Pilot Study of High-Dose, Intravenous Ascorbic Acid (Vitamin C) to Treat Hepatitis C
An Open-Label Pilot Study of the Safety, Tolerability and Anti-Viral Activity of High Dose Intravenous Ascorbic Acid in Patients Chronically Infected With Hepatitis C Virus Genotype 1, Who Have Failed Prior Therapy With Interferon-alpha and Ribavirin

The purpose of this pilot study is to learn whether high doses of ascorbic acid (vitamin c), given intravenously to patients with chronic hepatitis due to infection with the genotype 1 version of the hepatitis C virus, are safe, well-tolerated and able to reduce the amount of virus circulating in the patients' blood.

Hepatitis C virus (HCV) chronically infects 1% to 3% of the world's population, including about 3.9 million infected patients in the United States, with an estimated 36,000 new cases in the US each year. 70-85% of infected individuals develop a chronic infection complicated by chronic liver disease during the next 20 to 30 years, which is the tenth leading cause of death in the US. HCV is implicated in the development of hepato-cellular carcinoma. Chronic HCV hepatitis is the most frequent reason for liver transplantation. HCV genotype 1 is the most common genetic variant of HCV causing HCV hepatitis in the US. It responds less well to conventional anti-HCV treatment than the other HCV genotypes, so that 60% of genotype 1 patients fail conventional therapy due to the virus's resistance to treatment and/or due to toxic side effects of the therapy.

Extracellular levels of ascorbic acid (vitamin c) attainable only by high-dose, intravenous administration, are reported to have in vitro and in vivo anti-cancer and anti-viral effects in humans and animals. Ascorbic acid briefly generates extracellular hydrogen peroxide, an oxidative stress specifically toxic to cancer cells and cells infected with viruses, including HCV, but not to normal cells. High-dose, intravenous ascorbic acid has been given to large numbers of patients, particularly cancer patients, with anecdotal reports of good safety and occasional benefit. Given the foregoing, the investigators propose that there is sufficient rationale for a careful pilot study of the safety and anti-viral efficacy of infused ascorbic acid in HCV genotype 1 hepatitis.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis C
Dietary Supplement: ascorbic acid (vitamin C)
intravenous vitamin C, 25 to 100 grams, once or twice a week, for five months
Other Name: Vitamin C
Experimental: Ascorbic Acid (Vitamin C)
Intervention: Dietary Supplement: ascorbic acid (vitamin C)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
10
June 2012
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • hepatitis C, genotype 1
  • failed treatment with interferon-alpha and ribavirin
  • abstain from alcohol consumption for the duration of the study

Exclusion Criteria:

  • cirrhosis
  • decompensated liver disease
  • glucose6phosphate dehydrogenase deficiency
  • AST or ALT more than 5 times upper limit of normal
  • platelets less than 125,000
  • diabetes mellitus
  • alcohol and/or drug abuse within 1 year of screening
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01250743
FRI-101
No
Michael A Catalano MD, Research Director, Health Innovations, Frontier Research Institute
Health Innovations, Frontier Research Institute
Not Provided
Principal Investigator: Jeanne A Drisko, MD University of Kansas
Study Director: Michael A Catalano, MD Frontier Research Institute/Health Innovations
Study Chair: Terry A Grossman, MD Frontier Research Institute/Health Innovations
Health Innovations, Frontier Research Institute
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP