Long Term Interferon for Patients Who Did Not Clear Hepatitis C Virus With Standard Treatment

Summary

The HALT-C Trial is a National Institute of Diabetes and Digestive and Kidney Diseases sponsored, randomized clinical trial of long-term use of Peginterferon alfa-2a (pegylated interferon) in patients who failed to respond to prior interferon treatment. All patients who enter the trial will be treated for 6 months with Peginterferon alfa-2a and Ribavirin. Patients who respond to this 6 month treatment will continue to be treated for an additional 6 months.

Patients who do not respond to this treatment will be eligible for the long-term maintenance phase of this study where patients will be randomly selected to be treated with Peginterferon alfa-2a or to discontinue treatment for 3.5 years. Patients in both arms of this study will be followed closely with quarterly study visits.

The combination of peginterferon plus ribavirin has recently been approved by the FDA for treatment of chronic hepatitis C. Patients who remain HCV-RNA positive after being treated for at least 6 months with peginterferon and ribavirin outside of this study may be eligible to directly enter the randomized portion of the HALT-C Trial.

The HALT-C study is designed to determine if continuing interferon long-term over several years will suppress Hepatitis C virus, prevent progression to cirrhosis, prevent liver cancer and reduce the need for liver transplantation.

Conditions

• Chronic Hepatitis c
• Cirrhosis, Liver
• Fibrosis, Liver
• Hepatic Cirrhosis

Interventions

DRUG

Peginterferon alfa-2a + Ribavirin

Peginterferon alfa-2a 180 mcg/week injection, for 24 weeks, plus 1000-1200 mg Ribavirin oral (prescribed according to weight \<75 kg, \>75 kg) daily in two divided doses for 24 weeks

DRUG

Peginterferon alfa-2a

90 mcg/week injection, for 3.5 years

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

• National Institute on Minority Health and Health Disparities (NIMHD)

  collaborator NIH

• National Cancer Institute (NCI)

  collaborator NIH

• Hoffmann-La Roche

  collaborator INDUSTRY

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

  lead NIH

Principal Investigators

• Gregory T. Everson, M.D. · UCHSC (University of Colorado)

• Adrian M. Di Bisceglie, M.D. · St. Louis University

• William M. Lee, M.D. · University of Texas, Southwestern Medical Center at Dallas

• Marc Ghany, M.D. · LDS, NIDDK, NIH

• Jules L. Dienstag, M.D. · Massachusetts General Hospital

• Mitchell Shiffman, M.D. · Medical College of Virginia

• Anna Lok, M.D. · University of Michigan

• Tim Morgan, M.D. · University of California-Irvine/VA Medical Center-Long Beach

• Karen Lindsay, M.D., M.M.M. · USC School of Medicine

• Gyongyi Szabo, M.D., Ph.D. · UMass Medical School

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2000-06-30

Primary Completion

2007-04-30

Completion

2009-10-31

FDA Drug

Yes

Countries

• United States

Study Locations