SyNCH
Single and Multiple Dose Escalation Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Orally Administered Silymarin (Legalon) in Non-Cirrhotic Subjects With Chronic Hepatitis C or Non-Alcoholic Fatty Liver Disease
Sponsor study identifier
Secondary identifiers
interventional
56
1 country
5
Study Start
November 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2008
Actual (reported)Study Completion
February 2008
Actual (reported)The purpose of this study is to determine the safety and tolerability of different dosages of silymarin on subjects with Hepatitis C or Non-Alcoholic Fatty Liver Disease.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2008
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 16, 2006
Actual (reported)October 18, 2006
Actual (reported)November 2006
Date type not reportedThis date has not been verified as actual or estimated.
January 2008
Actual (reported)February 2008
Actual (reported)Adverse events
10 days
Placebo and 140 mg single dose + every 8 hours
Placebo and 280 mg single dose
Placebo and 280mg every 8 hours
Placebo
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
University of Pittsburgh, Graduate School of Public Health
Pittsburgh, Pennsylvania, 15261, United States
Schrieber SJ, Hawke RL, Wen Z, Smith PC, Reddy KR, Wahed AS, Belle SH, Afdhal NH, Navarro VJ, Meyers CM, Doo E, Fried MW. Differences in the disposition of silymarin between patients with nonalcoholic fatty liver disease and chronic hepatitis C. Drug Metab Dispos. 2011 Dec;39(12):2182-90. doi: 10.1124/dmd.111.040212. Epub 2011 Aug 24.
K. Rajender Reddy, MD
University of Pennsylvania
Victor Navarro, MD
Thomas Jefferson University
Nezam Afdhal, MD
Beth Israel Deaconess Medical Center
Michael Fried, MD
University of North Carolina
56 participants (actual enrollment reported by the registry).
First Submitted
October 16, 2006
First Posted
October 18, 2006
Study Start
November 2006
Date type not reportedThis date has not been verified as actual or estimated.
Silymarin in NAFLD
Study of Bavituximab in Patients With Chronic Hepatitis C Virus Infection
Placebo and 280 single dose + every 8 hours
Placebo and 560 mg single dose + every 8 hours
Placebo and 560 mg single dose + every 8 hours
Placebo and 700 mg single dose + every 8 hours
140 mg every 8 hours
280 mg single dose
280 mg single dose + every 8 hours
560 mg single dose + every 8 hours
560 mg single dose + every 8 hours
280 mg every 8 hours
700 mg single dose + every 8 hours
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
January 2008
Actual (reported)Study Completion
February 2008
Actual (reported)Last Updated
February 20, 2008
Record last verified: 2008-02
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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