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Long Term Interferon for Patients Who Did Not Clear Hepatitis C Virus With Standard Treatment (HALT-C)

This study has been completed.
Sponsor:
Collaborators:
Hoffmann-La Roche
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00006164
First received: August 8, 2000
Last updated: January 12, 2010
Last verified: January 2010

August 8, 2000
January 12, 2010
June 2000
April 2007   (final data collection date for primary outcome measure)
  • 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 [ Time Frame: 1400 days (3.85 years) post randomization ] [ Designated as safety issue: No ]
  • Increase in Ishak Fibrosis Score by 2 Points or More at 2 or 4 Year Biopsies [ Time Frame: 1400 days (3.85 years) post randomization ] [ Designated as safety issue: No ]
  • Death From Any Cause [ Time Frame: 1400 days (3.85 years) post randomization ] [ Designated as safety issue: Yes ]
  • Development of Hepatocellular Carcinoma (HCC) [ Time Frame: 1400 days (3.85 years) post randomization ] [ Designated as safety issue: No ]
  • Child-Turcotte-Pugh (CTP) Score of 7 or Higher at Two Consecutive Study Visits [ Time Frame: 1400 days (3.85 years) post randomization ] [ Designated as safety issue: No ]
  • Variceal Hemorrhage [ Time Frame: 1400 days (3.85 years) post randomization ] [ Designated as safety issue: No ]
  • Ascites [ Time Frame: 1400 days (3.85 years) post randomization ] [ Designated as safety issue: No ]
  • Spontaneous Bacterial Peritonitis [ Time Frame: 1400 days (3.85 years) post randomization ] [ Designated as safety issue: No ]
  • Hepatic Encephalopathy [ Time Frame: 1400 days (3.85 years) post randomization ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00006164 on ClinicalTrials.gov Archive Site
  • Serious Adverse Events [ Time Frame: 1400 days (3.85 years) post randomization ] [ Designated as safety issue: Yes ]
  • Events Requiring Dose Reductions (in Both Treatment Groups). [ Time Frame: 1400 days (3.85 years) post randomization ] [ Designated as safety issue: Yes ]
  • Changes in Fibrosis From Baseline at Year 2 or Year 4 Biopsy. [ Time Frame: 1400 days (3.85 years) post randomization ] [ Designated as safety issue: No ]
  • Presumed Hepatocellular Carcinoma (HCC) [ Time Frame: 1400 days (3.85 years) post randomization ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: 1400 days (3.85 years) post randomization ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Long Term Interferon for Patients Who Did Not Clear Hepatitis C Virus With Standard Treatment
Hepatitis C Antiviral Long-term Treatment Against Cirrhosis Trial (HALT-C)

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Chronic Hepatitis C
  • Cirrhosis, Liver
  • Fibrosis, Liver
  • Hepatic Cirrhosis
  • 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
    Other Names:
    • Pegasys (Hoffman-La Roche)
    • Copegus (Hoffman-La Roche)
  • Drug: Peginterferon alfa-2a
    90 mcg/week injection, for 3.5 years
    Other Name: Pegasys (Hoffman-La Roche)
  • Experimental: 1
    Peg-interferon alfa-2a 90 mcg/week
    Interventions:
    • Drug: Peginterferon alfa-2a + Ribavirin
    • Drug: Peginterferon alfa-2a
  • Active Comparator: 2
    Standard of care followup
    Intervention: Drug: Peginterferon alfa-2a + Ribavirin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1050
October 2009
April 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006164
HALT C, N01-DK-9-2328, N01-DK-9-2323, N01-DK-9-2324, N01-DK-9-2325, N01-DK-9-2326, N01-DK-9-2321, N01-DK-9-2327, N01-DK-9-2319, N01-DK-9-2318, N01-DK-9-2320, N01-DK-9-2322
Yes
James E. Everhart, MD, MPH, Project Officer, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • National Center on Minority Health and Health Disparities (NCMHD)
  • National Cancer Institute (NCI)
  • Hoffmann-La Roche
Principal Investigator: Gregory T. Everson, M.D. UCHSC (University of Colorado)
Principal Investigator: Adrian M. Di Bisceglie, M.D. St. Louis University
Principal Investigator: William M. Lee, M.D. UTSW-Dallas
Principal Investigator: Marc Ghany, M.D. LDS, NIDDK, NIH
Principal Investigator: Jules L. Dienstag, M.D. Massachusetts General Hospital
Principal Investigator: Mitchell Shiffman, M.D. Medical College of Virginia
Principal Investigator: Anna Lok, M.D. University of Michigan
Principal Investigator: Tim Morgan, M.D. University of California-Irvine/VA Medical Center-Long Beach
Principal Investigator: Karen Lindsay, M.D., M.M.M. USC School of Medicine
Principal Investigator: Gyongyi Szabo, M.D., Ph.D. UMass Medical School
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP