Phase II Trial of Silymarin for Patients With Chronic Hepatitis C Who Have Failed Conventional Antiviral Treatment

Summary

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 10 visits so recruitment will be limited to a geographically restricted area around participating clinical centers.

Conditions

• Chronic Hepatitis C

Interventions

DRUG

Silymarin

700mg dose (5 pills, three times daily) for 24-week treatment period

DRUG

Silymarin

420mg dose (5 pills, three times daily) for 24-week treatment period

OTHER

Placebo

Placebo (5 pills, three times daily) for 24-week treatment period

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• University of Pennsylvania

  collaborator OTHER

• University of North Carolina, Chapel Hill

  collaborator OTHER

• Thomas Jefferson University

  collaborator OTHER

• Beth Israel Deaconess Medical Center

  collaborator OTHER

• University of Pittsburgh

  collaborator OTHER

• National Center for Complementary and Integrative Health (NCCIH)

  lead NIH

Principal Investigators

• Michael Fried, MD · University of North Carolina, Chapel Hill

• Victor Navarro, MD · Thomas Jefferson University

• Nezam Afdhal, MD · Beth Israel Deaconess Medical Center

• K. Rajender Reddy, MD · University of Pennsylvania

• Steven Belle, PhD · University of Pittsburgh

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-04-30

Primary Completion

2011-01-31

Completion

2011-01-31

Countries

• United States

Study Locations