Q-Trial in Patients With Hepatitis C

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by University of California, Los Angeles.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
American Association for Cancer Research
Tower Cancer Research Foundation
Information provided by (Responsible Party):
SAMUEL FRENCH, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01438320
First received: September 14, 2011
Last updated: September 20, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Chronic Hepatitis C
Dietary Supplement: Quercetin
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of Quercetin in Patients With Hepatitis C

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 20
Study Start Date: July 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Quercetin
Quercetin is a bioflavonoid.
Dietary Supplement: Quercetin
Bioflavonoid

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01438320

Contacts
Contact: Nu Lu, M.D. 808-387-8039 NLu@mednet.ucla.edu
Contact: Samuel W French, M.D., Ph.D. 310-267-2795 SFrench@mednet.ucla.edu

Locations
United States, California
UCLA Jonsson Comprehensive Cancer Center. Factor Building Recruiting
los Angeles, California, United States, 90095
Contact: Nu Lu, M.D.    808-387-8039    NLu@mednet.ucla.edu   
Contact: Samuel W French, M.D., Ph.D.    310-267-2795    SFrench@mednet.ucla.edu   
Sub-Investigator: Simon Beaven, M.D., Ph.D.         
Sub-Investigator: Steven H Han, M.D         
Sub-Investigator: Sammy Saab, MD, MPH         
Sub-Investigator: Amy McClune, M.D.         
Principal Investigator: Samuel W French, M.D., Ph.D.         
Principal Investigator: Nu Lu, M.D.         
Sponsors and Collaborators
University of California, Los Angeles
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
  More Information

Additional Information:
Publications:
Responsible Party: SAMUEL FRENCH, Assistant Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01438320     History of Changes
Other Study ID Numbers: IRB#10-04-063-01, 1R01DK090794-01A1
Study First Received: September 14, 2011
Last Updated: September 20, 2011
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of California, Los Angeles:
Treatment naive
Contraindications to standard therapies
Alternative hepatitis C therapy

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Quercetin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2014