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Chronic Hepatitis CPhase 1QNCT01438320

Q-Trial in Patients With Hepatitis C

A Phase 1 study testing Quercetin in people with Chronic Hepatitis C, run by University of California, Los Angeles at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Chronic Hepatitis C
What is being tested?
Quercetin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteUnited States
Study dates
Jul 2011to Jun 2014
Phase
Phase 1
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UCLA Jonsson Comprehensive Cancer Center. Factor Building

    Los Angeles, California, 90095

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Quercetin
Keywords
Treatment naive, Contraindications to standard therapies, Alternative hepatitis C therapy
Medical subject headings
Hepatitis C, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QuercetinDietary supplement

    Bioflavonoid

Study groups in NCT01438320
Study groupRoleWhat they receive
QuercetinExperimentalQuercetin is a bioflavonoid.
Receives: Dietary Supplement: Quercetin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: up to 32 weeks

Secondary outcomes (1)

  1. Hepatitis C Viral Load Assessment with Quercetin Given Over 28 days

    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.

    Measured: 28 days during drug phase. Possibly this could go further for 32 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2011 (estimated)
  2. Study startJul 2011
  3. Primary completionJun 2014
  4. Study completionJun 2014

Resources

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Participant
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01438320
Sponsor's protocol ID
IRB#10-04-063-01
Other IDs
1R01DK090794-01A1
Acronym
Q
Status last verified
Mar 2015
First submitted
14 Sep 2011
Last updated
20 Mar 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Gonzalez O, Fontanes V, Raychaudhuri S, Loo R, Loo J, Arumugaswami V, Sun R, Dasgupta A, French SW. The heat shock protein inhibitor Quercetin attenuates hepatitis C virus production. Hepatology. 2009 Dec;50(6):1756-64. doi: 10.1002/hep.23232.

    PubMed 19839005

  • Lu NT, Crespi CM, Liu NM, Vu JQ, Ahmadieh Y, Wu S, Lin S, McClune A, Durazo F, Saab S, Han S, Neiman DC, Beaven S, French SW. A Phase I Dose Escalation Study Demonstrates Quercetin Safety and Explores Potential for Bioflavonoid Antivirals in Patients with Chronic Hepatitis C. Phytother Res. 2016 Jan;30(1):160-8. doi: 10.1002/ptr.5518. Epub 2015 Dec 1.

    PubMed 26621580

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Quercetin in people with Chronic Hepatitis C, run by University of California, Los Angeles 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 18 inclusion and 10 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: finished, as of the sponsor's last update on 20 Mar 2015. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

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). 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 NCT01438320, 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 20 Mar 2015.

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Q-Trial in Patients With Hepatitis C (NCT01438320) | AzTrials