Safety, Metabolism, and Antioxidant Activity of Silymarin and Green Tea Extract in Patients With Chronic Hepatitis C
Steady-State Pharmacokinetic Interactions of Green Tea Catechins and Silymarin Flavonolignans in Treatment Naïve Patients With Chronic Hepatitis C Infection
3 other identifiers
interventional
28
1 country
1
Brief Summary
The purpose of this study is to determine if the safety, metabolism, and antioxidant activity of silymarin and green tea extract are changed when they are given in combination to patients with chronic hepatitis C infection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Nov 2009
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 20, 2009
CompletedFirst Posted
Study publicly available on registry
November 23, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedApril 18, 2017
June 1, 2014
3.4 years
November 20, 2009
April 15, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the safety and tolerability of coadministered silymarin and green tea extract at different doses in patients with chronic hepatitis C.
November 2009 to September 2012
Secondary Outcomes (1)
To characterize the antioxidant effects of silymarin and EGCG administered alone or in combination.
November 2009 to September 2012
Study Arms (2)
low dose silymarin and low dose EGCG
EXPERIMENTALhigh dose silymarin and low dose EGCG
EXPERIMENTALInterventions
capsules, 700 mg, twice daily, 12 days
capsules, 196.5 mg, twice daily, 12 days
Eligibility Criteria
You may qualify if:
- Subjects will be eligible for enrollment in this study if they meet the following criteria:
- Males or females; age at least 18 years at screening
- Negative urine pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of silymarin. Females of childbearing potential must be using two reliable forms of effective contraception during the study (while on drug and during follow-up)
- Hepatitis C virus (HCV) patients
- Any HCV genotype
- Never been treated or received less than 50% of standard peg-interferon-based therapy.
- No interferon-based therapy in the previous 6 months
- Serum HCV RNA above quantifiable level of detection by the assay, within 1 year of screening.
- Before entering the study, subjects must agree not to consume alcohol for 48 hours prior to PK sampling days or while on study.
You may not qualify if:
- Subjects with any of the following will not be eligible for participation:
- Use of other milk thistle or green tea preparations within 30 days of Study Visit 1 (Day 1)
- Use of other antioxidants such as vitamin E, vitamin C, glutathione, alpha-tocopherol, within 30 days of Study Visit 1 (Day 1). A multivitamin at standard doses will be allowed.
- Use of diets containing \> 6 servings per day, or 4-6 servings per day from \> 8 of the vegetables and fruits listed in Appendix 2.
- Allergy/sensitivity to milk thistle, green tea or their preparations
- Inability to tolerate milk products (lactose intolerant)
- Use of any interferon-based therapy in the last 6 months.
- Use of warfarin, metronidazole or chronic use of acetaminophen greater than two grams per day
- Previous liver biopsy that demonstrated presence of cirrhosis or previous liver biopsy that demonstrated greater than or equal to 15% steatosis or evidence of steatohepatitis
- Positive test for anti-HIV or HBsAg within 3 years of screening
- Positive urine drug screen for drugs of abuse at screening
- Alcohol consumption of more than one drink or equivalent (\>12 grams) per day. Patients who consumed more than this in the past must have maintained a level 12 grams or less per day of alcohol consumption for at least six months prior to screening.
- History of other chronic liver disease, including metabolic diseases, documented by appropriate test(s)
- Women with ongoing pregnancy or breast-feeding, or contemplating pregnancy
- Platelet count \<130,000 cells/mm3.
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of North Carolina at Chapel Hill- UNC Health Care
Chapel Hill, North Carolina, 27514, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roy L Hawke, PhD, PharmD
UNC School of Pharmacy
- STUDY CHAIR
Michael W Fried, MD
University of North Carolina, Chapel Hill
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2009
First Posted
November 23, 2009
Study Start
November 1, 2009
Primary Completion
April 1, 2013
Study Completion
July 1, 2013
Last Updated
April 18, 2017
Record last verified: 2014-06