Status:
COMPLETED
Q-Trial in Patients With Hepatitis C
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
American Association for Cancer Research
Tower Cancer Research Foundation
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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.
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01438320
Start Date
July 1 2011
End Date
June 1 2014
Last Update
March 20 2015
Active Locations (1)
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1
UCLA Jonsson Comprehensive Cancer Center. Factor Building
Los Angeles, California, United States, 90095