Q-Trial in Patients With Hepatitis C

NCT01438320 | Completed Phase 1 DMC

• 2 other identifiers: IRB#10-04-063-011R01DK090794-01A1
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Hepatitis C

Keywords

Treatment naive; Contraindications to standard therapies; Alternative hepatitis C therapy

Outcome Measures

Primary Outcomes (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.

  up to 32 weeks

Secondary Outcomes (1)

• Hepatitis C Viral Load Assessment with Quercetin Given Over 28 days

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

Study Arms (1)

Quercetin

EXPERIMENTAL

Quercetin is a bioflavonoid.

Dietary Supplement: Quercetin

Interventions

Quercetin DIETARY_SUPPLEMENT

Bioflavonoid

Quercetin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• American Association for Cancer Research: collaborator
• Tower Cancer Research Foundation: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

UCLA Jonsson Comprehensive Cancer Center. Factor Building

Los Angeles, California, 90095, United States

Location

Related Publications (2)

• 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.

  PMID: 19839005 BACKGROUND

• 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.

  PMID: 26621580 DERIVED

Related Links

• Media Release regarding exciting in-vitro study of Quercetin against hepatitis C

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

Quercetin

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Flavonols; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Samuel W French, MD/PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Nu Lu, M.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 14, 2011
• First Posted: September 22, 2011
• Study Start: July 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: March 20, 2015

Record last verified: 2015-03

Locations

US (1)