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

Status Terminated

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.

Clinical Trial 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. ;

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

Clinical Trial Details

NCT number	NCT01250743
Study type	Interventional
Source	Health Innovations, Frontier Research Institute
Contact
Status	Terminated
Phase	N/A
Start date	January 2009
Completion date	June 2012

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03686722` - Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin	Phase 1
Recruiting	`NCT04510246` - Link Hepatitis C Notifications to Treatment in Tasmania	N/A
Completed	`NCT03413696` - Effects of Health Literacy and HCV Knowledge on HCV Treatment Willingness in HIV-coinfected Patients
Completed	`NCT03109457` - Hepatitis C Virus Detection in Oral Squamous Cell Carcinoma
Completed	`NCT03118674` - Harvoni Treatment Porphyria Cutanea Tarda	Phase 2
Completed	`NCT01458054` - Effect of Omeprazole and Ritonavir on GSK2336805 Pharmacokinetics in Healthy Adults	Phase 1
Completed	`NCT03740230` - An Observational Study of Maviret (Glecaprevir/Pibrentasvir) for Korean Chronic Hepatitis C Genotypes 1 to 6 Patients According to the Standard for Re-examination of New Drugs
Completed	`NCT03426787` - Helping Empower Liver and Kidney Patients	N/A
Completed	`NCT03627299` - Renal Transplants in Hepatitis C Negative Recipients With Nucleic Acid Positive Donors	Phase 4
Completed	`NCT00006301` - Immune Response to Hepatitis C Virus
Active, not recruiting	`NCT03949764` - The Kentucky Viral Hepatitis Treatment Study	Phase 4
Completed	`NCT03365635` - Administration of Zepatier (Grazoprevir Plus Elbasvir) in Chronic Hemodialysis (HD) Patients With Hepatitis C	Phase 4
Recruiting	`NCT04405024` - Pilot Study on the Feasibility of Systematic Hepatitis C Screening of Hospitalized Patients	N/A
Completed	`NCT04525690` - Improving Inpatient Screening for Hepatitis C	N/A
Completed	`NCT04033887` - Evaluation Study of RDTs Detecting Antibodies Against HCV
Withdrawn	`NCT04546802` - HepATocellular Cancer Hcv Therapy Study	Phase 3
Active, not recruiting	`NCT02961426` - Strategic Transformation of the Market of HCV Treatments	Phase 2/Phase 3
Completed	`NCT02683005` - Study of Hepatitis C Treatment During Pregnancy	Phase 1
Completed	`NCT03186313` - A Study to Evaluate the Safety and Efficacy of the Combined Single Dose of Dactavira Plus Or Dactavira in Egyptian Adults With Chronic Genotype 4 HCV Infection	Phase 3
Completed	`NCT02869776` - Integrating HCV and HIV Screening During the Era of HIV Antigen Testing	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms