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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Hepatitis C

Intervention / Treatment
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* Dietary Supplement: ascorbic acid (vitamin C)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ascorbic Acid (Vitamin C)<br> | Dietary Supplement: ascorbic acid (vitamin C)<br>* intravenous vitamin C, 25 to 100 grams, once or twice a week, for five months<br>* Other names: Vitamin C;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of participants with adverse events as a measure of safety and tolerability | clinical and/or laboratory adverse events | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anti-viral efficacy | measured by reduction of circulating hepatitis C viral levels | 6 months | 
| aspartate aminotransferase (AST or SGOT) | reduced circulating levels of AST (or SGOT), as a measure of liver inflammation | 6 months | 
| alanine aminotransferase (ALT or SGPT) | reduced circulating levels of ALT (or SGPT), as a measure of liver inflammation | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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genotype 1