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Sponsors and Collaborators: |
National Center for Complementary and Alternative Medicine (NCCAM) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) University of Pennsylvania University of North Carolina Thomas Jefferson University Beth Israel Deaconess Medical Center University of Pittsburgh |
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Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
ClinicalTrials.gov Identifier: | NCT00680342 |
Silymarin (Legalon), also known as milk thistle, is an alternative medicine commonly found in health food and vitamin stores. People with liver disease sometimes use silymarin because it is thought to have liver protecting effects; however, this benefit has not been proven. The purpose of this research study is to determine the effectiveness of silymarin and assess the safety of different silymarin doses in patients with varying severity of liver disease compared to a placebo (lactose pill).
Eligible subjects will be randomized to treatment with placebo or one of two dosages of Legalon® 420 mg or 700 mg administered orally thrice daily. Investigators and subjects will be masked to treatment assignment. The study design includes a screening period during which patients will undergo full medical evaluation to verify protocol eligibility and a treatment period of 24 weeks during which time clinic visits and laboratory studies will be performed every 2-4 weeks to monitor for safety and efficacy of therapy. Subjects will continue to be followed for an additional 12 weeks after the completion of study medication to monitor for adverse events and investigate post-treatment outcomes. Participation in this research study requires the subject to travel to the clinic for at least 11 visits so recruitment will be limited to a geographically restricted area around participating clinical centers.
Condition | Intervention | Phase |
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Non Cirrhotic Chronic Hepatitis C |
Drug: Silymarin Other: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Randomized, Double-Masked, Placebo-Controlled Phase II Study to Assess the Safety and Efficacy of a Standardized Orally Administered Silymarin Preparation (Legalon) for the Treatment of Non-Cirrhotic Patients With Chronic Hepatitis C Who Failed Conventional Antiviral Therapy |
Estimated Enrollment: | 153 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator
Placebo (lactose pill)
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Other: Placebo
Placebo (5 pills, three times daily) for 24-week treatment period
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2: Experimental
700mg of Legalon (silymarin) three times daily
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Drug: Silymarin
700mg dose (5 pills, three times daily) for 24-week treatment period
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3: Experimental
420mg Legalon (silymarin) three times daily
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Drug: Silymarin
420mg dose (5 pills, three times daily) for 24-week treatment period
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This proposal is a phase II study that will evaluate the safety and efficacy of silymarin for the treatment of subjects with chronic hepatitis C who did not respond to conventional antiviral therapy. The primary objectives of this study are to assess the safety and adverse event profile of silymarin over a range of doses compared to placebo and to assess efficacy of silymarin in normalizing serum aminotransferase activity in patients with chronic hepatitis C. Secondary objectives are to characterize the effect of silymarin on serum levels of HCV RNA and to explore relationships between silymarin therapy and serum biomarkers of HCV hepatic disease activity (oxidative stress, apoptosis, and fibrogenesis).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Michael Fried, MD | 919-966-2516 | mfried@med.unc.edu |
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | Recruiting |
Boston, Massachusetts, United States, 00215 | |
Principal Investigator: Nezam Afdhal, MD | |
United States, North Carolina | |
University of North Carolina | Recruiting |
Chapel Hill, North Carolina, United States, 27599 | |
Principal Investigator: Michael Fried, MD | |
United States, Pennsylvania | |
University of Pennsylvania | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Principal Investigator: K. Rajender Reddy, MD | |
Thomas Jefferson University | Recruiting |
Philadelphia, Pennsylvania, United States, 19107 | |
Principal Investigator: Victor Navarro, MD | |
University of Pittsburgh | Active, not recruiting |
Pittsburgh, Pennsylvania, United States, 15213 |
Principal Investigator: | Michael Fried, MD | The University of North Carolina, Chapel Hill |
Principal Investigator: | Victor Navarro, MD | Thomas Jefferson University |
Principal Investigator: | Nezam Afdhal, MD | Beth Isreal Deaconess Medical Center |
Principal Investigator: | K. Rajender Reddy, MD | University of Pennsylvania |
Principal Investigator: | Steven Belle, PhD | University of Pittsburgh |
Responsible Party: | NCCAM/NIDDK/UNC/UPenn/TJU/BIDMC/UPitt ( SyNCH Steering Committee ) |
Study ID Numbers: | U01 AT003566, IND 74,887 |
Study First Received: | May 15, 2008 |
Last Updated: | July 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00680342 |
Health Authority: | United States: Food and Drug Administration; United States: Federal Government; United States: Institutional Review Board |
hepatitis C |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Chronic |
Silymarin Hepatitis, Viral, Human Hepatitis C Hepatitis C, Chronic |
RNA Virus Infections Antioxidants Molecular Mechanisms of Pharmacological Action Flaviviridae Infections |
Physiological Effects of Drugs Protective Agents Pharmacologic Actions |