Q-Trial in Patients With Hepatitis C (Q)

March 18, 2015 updated by: SAMUEL FRENCH, University of California, Los Angeles

A Phase 1 Study of Quercetin in Patients With Hepatitis C

The goal of this study is to translate laboratory findings that Quercetin, a bioflavonoid, is safe and has antiviral activity in people with hepatitis C.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • los Angeles, California, United States, 90095
        • UCLA Jonsson Comprehensive Cancer Center. Factor Building

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All participants will have detectable HCV RNA in serum; stable viral load within the previous year (no fluctuation > 2 log scale).
  • All participants are either treatment-naïve and unwilling to be treated with standard HCV therapies, or were not able to tolerate hepatitis C antiviral due to side effects and completed treatment more than 6 months prior to enrollment into our trial.
  • Age range will be from 18-65 years old
  • ECOG performance status <2 (Karnofsky >60%)
  • Life expectancy of greater than 12 months

  • Participants must have:

    • leukocytes >3,000/mcL
    • absolute neutrophil count >1,500/mm(3)
    • hemoglobin >13 or >12 g/dL for men/women
    • platelets >125,000 K/mm(3)
    • total bilirubin <1.5 g/dL
    • AST(SGOT)/ALT(SGPT) <10 X institutional upper limit of normal
    • Albumin >3.4g/dL
    • INR <1.2
    • Alpha Feto-protein <50 ng/mL
    • creatinine within normal institutional limits OR
    • creatinine clearance >60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal.
  • All participants must exhibit the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Participants who are currently on interferon +/- ribavirin or any other anti-viral therapies are excluded from our study. Participants who have previously been treated with hepatitis C antiviral therapy must have recovered from any adverse events due to the agent(s) administered. In addition, their last antiviral therapy must be more than six months prior to their enrollment in our study
  • Participants may not be receiving any other investigational agents
  • Participants with decompensated liver disease or cirrhosis will be excluded from this trial
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to Quercetin or any bioflavonoid agent
  • According to a monogram published by the Natural Medicines Comprehensive Database, drug interactions with Quercetin have been reported to occur with quinolone antibiotics and inhibition of p-glycoprotein or various cytochrome P450 enzymes including CYP3A4/ CYP2C8/ CYP2C9/ CYP2D6. Quercetin interactions with drugs can be categorized into (1) moderate interaction to be avoided based on healthy volunteer studies and (2) moderate interaction to be monitored closely based on in vitro studies demonstrating potential theoretical reduced elimination and increased effects. Screening will be performed prior to treatment.
  • Participants with concurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, untreated/active cardiac arrhythmia, psychiatric illness, active moderate alcohol use, or any social situation that would limit compliance with study protocol will be excluded from our study.
  • In addition, participants with any other known hepatitis etiologies (hepatitis B co-infection, hemochromatosis, alpha-1 antitrypsin deficiency, Wilson Disease, autoimmune hepatitis, alcohol, drug, obesity induced liver disease); or those with hepatocellular carcinoma will be excluded from this study.
  • Pregnant women are excluded from this study.
  • Human immunodeficiency virus (HIV)-positive subjects are excluded from our study.
  • In addition to renal and hepatic laboratory requirements listed above, renal and liver transplant recipients will be excluded from our study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Quercetin
Quercetin is a bioflavonoid.
Dietary supplement: Quercetin
Bioflavonoid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Event Score Assessment of Quercetin Given over 28 days in hepatitis C patients who have contraindications to standard antiviral treatment
Time Frame: up to 32 weeks
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hepatitis C Viral Load Assessment with Quercetin Given Over 28 days
Time Frame: 28 days during drug phase. Possibly this could go further for 32 weeks.
Hepatitis C viral load will be monitored every 2 wks during the first 28 days when patients are taking Quercetin. After this period, if there is a positive antiviral activity that is seen, we continue to monitor viral load every month to see how long this effect will last.
28 days during drug phase. Possibly this could go further for 32 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
American Association for Cancer Research
Tower Cancer Research Foundation

Investigators

  • Principal Investigator: Samuel W French, MD/PhD, University of California, Los Angeles
  • Principal Investigator: Nu Lu, M.D., University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

September 14, 2011

First Submitted That Met QC Criteria

September 20, 2011

First Posted (Estimate)

September 22, 2011

Study Record Updates

Last Update Posted (Estimate)

March 20, 2015

Last Update Submitted That Met QC Criteria

March 18, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB#10-04-063-01
  • 1R01DK090794-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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