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 HCV. 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.

Condition	Treatment or Intervention	Phase
Chronic Hepatitis C Cirrhosis, Liver Fibrosis, Liver Hepatic Cirrhosis	Drug: Peginterferon alfa-2a + Ribavirin  Drug: Peginterferon alfa-2a	Phase III

Further Study Details: 

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Age at entry at least 18 years.
• Positive for Hepatitis C.
• Previous treatment with any interferon or interferon and ribavirin for at least 3 months.
• Documented non-response to treatment with interferon.
• A liver biopsy demonstrating significant liver scarring.

Exclusion Criteria:

• No other liver disease.
• No unstable major medical diseases or conditions.
• No major complications of cirrhosis.
• No recent abuse of alcohol or illicit drugs.

California
      University of California-Irvine/VA Medical Center-Long Beach, Long Beach,  California,  90822,  United States
      USC School of Medicine, Los Angeles,  California,  90033,  United States
Colorado
      UCHSC (University of Colorado), Denver,  Colorado,  80262,  United States
Connecticut
      University of Connecticut Health Center, Farmington,  Connecticut,  06030,  United States
Maryland
      Lds, Niddk, Nih, Bethesda,  Maryland,  20892-1800,  United States
Massachusetts
      Massachusetts General Hospital, Boston,  Massachusetts,  02114,  United States
      UMass Memorial HealthCare, University Campus, Worcester,  Massachusetts,  01655,  United States
Michigan
      University of Michigan, Ann Arbor,  Michigan,  48109,  United States
Missouri
      Saint Louis University, St. Louis,  Missouri,  63104,  United States
Texas
      University of Texas Southwestern - Dallas, Dallas,  Texas,  75390-9195,  United States
Virginia
      Medical College of Virginia, Richmond,  Virginia,  23298-0341,  United States

Study chairs or principal investigators

Gregory T. Everson, M.D.,  Principal Investigator,  UCHSC (University of Colorado)   
Adrian M. Di Bisceglie, M.D.,  Principal Investigator,  St. Louis University   
William M. Lee, M.D.,  Principal Investigator,  UTSW - Dallas   
Marc Ghany, M.D.,  Principal Investigator,  LDS, NIDDK, NIH   
Jules L. Dienstag, M.D.,  Principal Investigator,  Massachusetts General Hospital/ Harvard Medical School   
Mitchell Shiffman, M.D.,  Principal Investigator,  Medical College of Virginia   
Anna Lok, M.D.,  Principal Investigator,  University of Michigan   
Tim Morgan, M.D.,  Principal Investigator,  University of California-Irvine/VA Medical Center-Long Beach   
Karen Lindsay, M.D.,  Principal Investigator,  USC School of Medicine   
Savant Mehta, M.D.,  Principal Investigator,  UMass Medical School   

Study ID Numbers:  HALT C; N01-DK-9-2328; N01-DK-9-2328; N01-DK-9-2323; N01-DK-9-2324; N01-DK-2325; N01-DK-9-2326; N01-DK-9-2321; N01-DK-9-2327; N01-DK-9-2319; N01-9-2318; N01-DK-9-2320; N01-DK-9-2322
Record last reviewed:  October 2004
Last Updated:  October 13, 2004
Record first received:  August 8, 2000
ClinicalTrials.gov Identifier:  NCT00006164
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08