Phase II Trial of Silymarin for Non-Cirrhotic Patients With Non-Alcoholic Steatohepatitis

Summary

Silymarin, 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).

Following a screening visit, patients with histologically confirmed NASH will be randomized to either placebo or one of two active treatment groups of silymarin (Legalon®). One active treatment group will receive 420 mg, each dose given three times daily, the other active treatment group will receive 700 mg, each dose given three times daily. Patients will be treated for 48-50 weeks. Participation in this research study requires the patient to travel to the clinic for at least 11 visits so recruitment will be limited to a geographically restricted area around participating clinical centers. Liver biopsy must be performed up to 12 months prior to, and immediately after, the treatment phase.

Conditions

• Non-alcoholic Steatohepatitis

Interventions

OTHER

Placebo

Placebo (5 pills, three times daily) for 48-50 week treatment period

DRUG

Silymarin 700 mg

700 mg dose (5 pills, three times daily) for 48-50 week treatment period

DRUG

Silymarin 420 mg

420 mg dose (5 pills, three times daily) for 48-50 week treatment period

Sponsors & Collaborators

• University of Pennsylvania

  collaborator OTHER

• University of North Carolina

  collaborator OTHER

• Thomas Jefferson University

  collaborator OTHER

• Beth Israel Deaconess Medical Center

  collaborator OTHER

• Brooke Army Medical Center

  collaborator FED

• University of Pittsburgh

  collaborator OTHER

• Madaus Inc

  lead INDUSTRY

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 H. Belle, PhD · University of Pittsburgh

• Stephen A. Harrison, MD · Brooke Army Medical Center

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

2012-11-30

Completion

2012-11-30

Countries

• United States

Study Locations