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

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01250743
• Other study ID #: FRI-101
• Status: Terminated
• Phase: N/A
• First received: November 29, 2010
• Last updated: February 17, 2011
• Start date: January 2009
• Est. completion date: June 2012

Study information

• Verified date: November 2010
• Source: Health Innovations, Frontier Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: June 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Dietary Supplement:
• ascorbic acid (vitamin C)
intravenous vitamin C, 25 to 100 grams, once or twice a week, for five months

Locations

Country	Name	City	State
United States	University of Kansas Medical Center, Department of Integrative Medicine	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Health Innovations, Frontier Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (2)

Chen Q, Espey MG, Krishna MC, Mitchell JB, Corpe CP, Buettner GR, Shacter E, Levine M. Pharmacologic ascorbic acid concentrations selectively kill cancer cells: action as a pro-drug to deliver hydrogen peroxide to tissues. Proc Natl Acad Sci U S A. 2005 Sep 20;102(38):13604-9. Epub 2005 Sep 12. — View Citation

Choi J, Lee KJ, Zheng Y, Yamaga AK, Lai MM, Ou JH. Reactive oxygen species suppress hepatitis C virus RNA replication in human hepatoma cells. Hepatology. 2004 Jan;39(1):81-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of participants with adverse events as a measure of safety and tolerability	clinical and/or laboratory adverse events	6 months	Yes
Secondary	anti-viral efficacy	measured by reduction of circulating hepatitis C viral levels	6 months	No
Secondary	aspartate aminotransferase (AST or SGOT)	reduced circulating levels of AST (or SGOT), as a measure of liver inflammation	6 months	No
Secondary	alanine aminotransferase (ALT or SGPT)	reduced circulating levels of ALT (or SGPT), as a measure of liver inflammation	6 months	No