Hepatitis C
Conditions
Keywords
genotype 1
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTascorbic acid (vitamin C)
intravenous vitamin C, 25 to 100 grams, once or twice a week, for five months
Sponsors
Health Innovations, Frontier Research Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of participants with adverse events as a measure of safety and tolerability | 6 months | clinical and/or laboratory adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| anti-viral efficacy | 6 months | measured by reduction of circulating hepatitis C viral levels |
| aspartate aminotransferase (AST or SGOT) | 6 months | reduced circulating levels of AST (or SGOT), as a measure of liver inflammation |
| alanine aminotransferase (ALT or SGPT) | 6 months | reduced circulating levels of ALT (or SGPT), as a measure of liver inflammation |
Countries
United States
Outcome results
None listed