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

Brief Title

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

Official Title

Hepatitis C Antiviral Long-term Treatment Against Cirrhosis Trial (HALT-C)

Brief 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.
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Progression of Liver Disease as Indicated by Death, Hepatic Decompensation, Hepatocellular Carcinoma, or for Patients With Noncirrhotic Fibrosis at Baseline, an Increase in the Ishak Hepatic Fibrosis Score of 2 or More Points

Secondary Outcome

 Serious Adverse Events

Condition

Chronic Hepatitis c

Intervention

Peginterferon alfa-2a + Ribavirin

Study Arms / Comparison Groups

 1
Description:  Peg-interferon alfa-2a 90 mcg/week

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

1050

Start Date

June 2000

Completion Date

October 2009

Primary Completion Date

April 2007

Eligibility 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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Gregory T. Everson, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00006164

Organization ID

HALT C

Secondary IDs

N01-DK-9-2328

Responsible Party

Sponsor

Study Sponsor

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

Collaborators

 National Institute of Allergy and Infectious Diseases (NIAID)

Study Sponsor

Gregory T. Everson, M.D., Principal Investigator, UCHSC (University of Colorado)


Verification Date

April 2020