A Phase 1 Study of Quercetin in Patients With Hepatitis C
Chronic hepatitis C (HCV) is a serious chronic condition in the United States affecting
millions of people and is the cause of rates of hepatocellular carcinoma recently doubling
in the US. Treatment of hepatitis C is proven to be an effective secondary prevention of
liver cancer. Current standard antiviral treatments exclude 70-80% of hepatitis C patients
from therapies due to intolerable side effects. Our laboratory efforts identified a
potential novel approach to hepatitis C treatment and hepatocellular carcinoma prevention
with Quercetin, a heat shock protein inhibitor.
This is a Phase I study evaluating the safety and tolerability of Quercetin in hepatitis C
patients who have contraindications to standard antiviral treatment (both treatment naïve
patients who decline standard therapy, patients who previously had standard treatments with
relapse, as well as those who had intolerable side effects previously). The investigators
recently demonstrated that the flavonoid Quercetin inhibits hepatitis C viral production in
tissue culture, at least partially through its inhibition of heat shock protein expression.
This represents a novel mechanism for treating hepatitis C infection. Quercetin also has
low toxicity. These promising characteristics motivate the proposed Phase I study.
Patients will be recruited through the UCLA Pfleger Liver Institute and treated on an
outpatient basis. Toxicity will be closely monitored and reported. Viral load response
will be evaluated as a secondary endpoint. The anticipated total number of patients
enrolled in the trial will be 20. All patients will be followed for 8 months after taking
this first dose of study medication. Patients exhibiting a viral load response will have
extended follow-up, ranging from a total follow-up of 12-24 months, to determine persistence
of this response.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Adverse Event Score Assessment of Quercetin Given over 28 days in hepatitis C patients who have contraindications to standard antiviral treatment
Primary outcome for the study will be safety. The investigators will track various laboratory parameters including viral loads and see patients every 2 weeks during our drug phase which is 28 days. After that follow patients every month to see how long antiviral activity will persist if we do see a positive outcome.
up to 32 weeks
Samuel W French, MD/PhD
University of California, Los Angeles
United States: Institutional Review Board
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