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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: 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
Information provided by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00006164
  Purpose

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

MedlinePlus related topics:   Cirrhosis    Hepatitis    Hepatitis C   

Drug Information available for:   Ribavirin    Peginterferon Alfa-2a    Interferon alfa-2b    Interferons   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:   Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis Trial (HALT-C)

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Increase in Ishak fibrosis score by 2 points or more at 2 or 4 year biopsies [ Time Frame: 2 years and 4 years ] [ Designated as safety issue: No ]
  • Death from any cause [ Time Frame: up to 4 years ] [ Designated as safety issue: Yes ]
  • Development of HCC [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
  • CTP score of 7 or higher at two consecutive study visits [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
  • Variceal hemorrhage [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
  • Ascites [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
  • Spontaneous bacterial peritonitis [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
  • Hepatic encephalopathy [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serious adverse events [ Time Frame: up to 4 years ] [ Designated as safety issue: Yes ]
  • Events requiring dose reductions (in both treatment groups). [ Time Frame: up to 4 years ] [ Designated as safety issue: Yes ]
  • Changes in fibrosis from baseline at year 2 or year 4 biopsy. [ Time Frame: Year 2 and Year 4 ] [ Designated as safety issue: No ]
  • Presumed Hepatocellular Carcinoma [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]

Enrollment:   1050
Study Start Date:   June 2000
Estimated Study Completion Date:   October 2009
Primary Completion Date:   April 2007 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
Peg-interferon alfa-2a 90 mcg/week
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
2: Active Comparator
Standard of care followup
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

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006164

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

Sponsors and Collaborators

Investigators
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/ Harvard Medical School    
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    
  More Information


HALT-C Web Site  This link exits the ClinicalTrials.gov site
 

Publications indexed to this study:

Responsible Party:   National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ( James E. Everhart, MD, MPH, Project Officer )
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
First Received:   August 8, 2000
Last Updated:   January 3, 2008
ClinicalTrials.gov Identifier:   NCT00006164
Health Authority:   United States: Food and Drug Administration

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
liver disease  
hepatitis c virus  
antiviral agent  
cirrhosis  

Study placed in the following topic categories:
Interferon-alpha
Liver Diseases
Hepatitis, Chronic
Fibrosis
Interferons
Ribavirin
Hepatitis, Viral, Human
Liver Cirrhosis
Hepatitis
Virus Diseases
Digestive System Diseases
Peginterferon alfa-2a
Hepatitis C
Interferon Alfa-2a
Hepatitis C, Chronic
Interferon Alfa-2b

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Flaviviridae Infections
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Pathologic Processes
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on December 03, 2008




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