Hepatitis CNCT01250743
A Pilot Study of High-Dose, Intravenous Ascorbic Acid (Vitamin C) to Treat Hepatitis C
A study testing ascorbic acid (vitamin C) in people with Hepatitis C, run by Health Innovations, Frontier Research Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- ascorbic acid (vitamin C)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hepatitis C, genotype 1
- failed treatment with interferon-alpha and ribavirin
- abstain from alcohol consumption for the duration of the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center, Department of Integrative Medicine
Kansas City, Kansas, 66160
About this study
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
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.
Read the 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.
- Conditions
- Hepatitis C
- Being tested
- ascorbic acid (vitamin C)
- Keywords
- genotype 1
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ascorbic acid (vitamin C)Dietary supplement
Also called Vitamin C
intravenous vitamin C, 25 to 100 grams, once or twice a week, for five months
| Study group | Role | What they receive |
|---|---|---|
| Ascorbic Acid (Vitamin C) | Experimental | Not described Receives: Dietary Supplement: ascorbic acid (vitamin C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of participants with adverse events as a measure of safety and tolerability
clinical and/or laboratory adverse events
Measured: 6 months
Secondary outcomes (3)
anti-viral efficacy
measured by reduction of circulating hepatitis C viral levels
Measured: 6 months
aspartate aminotransferase (AST or SGOT)
reduced circulating levels of AST (or SGOT), as a measure of liver inflammation
Measured: 6 months
alanine aminotransferase (ALT or SGPT)
reduced circulating levels of ALT (or SGPT), as a measure of liver inflammation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2010 (estimated)
- Study startJan 2009
- Primary completionDec 2011 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Health Innovations, Frontier Research Institute
- Sponsor type
- University, hospital or other
- Investigators
- Jeanne A Drisko, MD, Principal investigator, University of Kansas Medical CenterMichael A Catalano, MD, Study director, Frontier Research Institute/Health InnovationsTerry A Grossman, MD, Study chair, Frontier Research Institute/Health Innovations
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01250743
- Sponsor's protocol ID
- FRI-101
- Status last verified
- Nov 2010
- First submitted
- 29 Nov 2010
- Last updated
- 18 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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. doi: 10.1002/hep.20001.
PubMed 14752826Chen 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. doi: 10.1073/pnas.0506390102. Epub 2005 Sep 12.
PubMed 16157892
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01250743
- Acronym / sponsor ID
- FRI-101
- Conditions
- Hepatitis C
- Keywords
- genotype 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Health Innovations, Frontier Research InstituteUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 1 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ascorbic Acid (Vitamin C) | Experimental | Dietary Supplement: ascorbic acid (vitamin C) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- hepatitis C, genotype 1
- failed treatment with interferon-alpha and ribavirin
- abstain from alcohol consumption for the duration of the study
Key exclusion criteria (7 listed)
- cirrhosis
- decompensated liver disease
- glucose6phosphate dehydrogenase deficiency
- AST or ALT more than 5 times upper limit of normal
- platelets less than 125,000
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ascorbic acid (vitamin C)Also: Vitamin Cintravenous vitamin C, 25 to 100 grams, once or twice a week, for five months | Dietary supplement | Ascorbic Acid (Vitamin C) |
Primary outcome
number of participants with adverse events as a measure of safety and tolerability
Time frame: 6 months
clinical and/or laboratory adverse events
3 secondary outcomes
anti-viral efficacy
Time frame: 6 months
aspartate aminotransferase (AST or SGOT)
Time frame: 6 months
alanine aminotransferase (ALT or SGPT)
Time frame: 6 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2011.
- Background: PubMed 14752826Choi 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. doi: 10.1002/hep.20001.
- Background: PubMed 16157892Chen 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. doi: 10.1073/pnas.0506390102. Epub 2005 Sep 12.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeanne A Drisko, MD principal investigator
University of Kansas Medical Center
Michael A Catalano, MD study director
Frontier Research Institute/Health Innovations
Terry A Grossman, MD study chair
Frontier Research Institute/Health Innovations
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ascorbic acid (vitamin C) in people with Hepatitis C, run by Health Innovations, Frontier Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of participants with adverse events as a measure of safety and tolerability (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01250743, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2011.