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Clinical Trial at KU Medical Center: HDIVAA-Hepatitis C

The study is recruiting people with chronic (longstanding) hepatitis C who have failed treatment with the usual therapy (interferon and ribavirin). It is known that considerable numbers of people with cancer and chronic viral hepatitis are receiving high doses of intravenous vitamin C from physicians as a treatment. When vitamin C is given in this manner, it is known that it acts like a drug and not a vitamin. It is not proven in scientifically designed treatment studies that high doses of intravenous vitamin C are safe, although high doses of intravenous vitamin C have been given to patients for over 30 years. No formal study has been done at these high doses in patients with hepatitis C. Currently, the FDA has not approved the use of high dose intravenous vitamin C (given through a vein in your arm) as a hepatitis treatment. High dose Vitamin C creates hydrogen peroxide around the infected cells. Researchers believe it is hydrogen peroxide that kills the virus.

You will receive 30 treatments of intravenous vitamin C over a period of 20 weeks, plus one month of follow-up after treatment is completed. Your hepatitis doctor must know you are planning to participate in this study. The study staff will notify your doctor by letter with your permission. The dose of intravenous vitamin C will be started at 25 grams and may be increased up to 100 grams, until your blood level of vitamin C after the infusion reaches a predetermined level, which other studies have suggested suppresses the growth of the hepatitis C virus. Each infusion will take from 50 to 200 minutes to complete. You will receive infusions twice a week for 10 weeks and then once a week for another 10 weeks.

For updated information, please visit the KU Medical Center web site: http://integrativemed.kumc.edu/research.htm

Published Mar 15, 2010 - 03:42 PM

Current Clinical Trials: Kansas City Gastroenterology and Hepatology

Topic: Clinical Trials

Clinical trials that are currently enrolling at Kansas City Gastroenterology and Hepatology

Naïve patients diagnosed with hepatitis C, genotype 1, may qualify for treatment utilizing pegylated interferon and Ribavirin plus a protease inhibitor.

There is also an opportunity for previously treated patients with hepatitis C, genotype 1, to receive treatment utilizing the above mentioned drug combinations. Documentation of prior treatment details such as drug name, dosing and viral count information throughout treatment is necessary to be eligible.

Non Alcoholic Steatohepatitis (NASH) is the number one cause of liver disease leading to cirrhosis in the United States, most commonly from obesity. Currently enrolling are two studies utilizing an appetite suppressant agent (approved in Europe) to reduce weight and examine the effect on underlying liver disease. One trial is intended for diabetics and the other is a non diabetic population.

Lastly, patients with active ulcerative colitis may qualify for a trial using an injectable anti-TNF agent. Patients however, cannot have previously treated with Infliximab, any anti-TNF agent or biological therapy.

Further eligibility to qualify for these studies will be determined by study protocol.

All treatment costs and medications are fully covered by the trials. Also once trial related care is complete all patients will be asked to continue care with their referring provider. For further information, contact Laurie Lynn, Study Coordinator, at Dr. Bradley Freilich's office with any questions or for further information, 816-361-5525.