Long Term Interferon for Patients Who Did Not Clear Hepatitis C Virus With Standard Treatment - Full Text View

Sponsor:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators:	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

Sponsor:

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

Collaborators:

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Hepatitis C Antiviral Long-term Treatment Against Cirrhosis Trial (HALT-C)

Resource links provided by NLM:

Genetics Home Reference related topics: North American Indian childhood cirrhosis

MedlinePlus related topics: Cirrhosis Hepatitis Hepatitis A Hepatitis C Liver Diseases

Drug Information available for: Ribavirin Peginterferon Alfa-2a Hepatitis A Vaccines Interferons

U.S. FDA Resources

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

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

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

Arms	Assigned Interventions
Experimental: 1 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 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)
Active Comparator: 2 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 Other Names: Pegasys (Hoffman-La Roche) Copegus (Hoffman-La Roche)

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

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

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
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

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

Responsible Party:	James E. Everhart, MD, MPH, Project Officer, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00006164 History of Changes
Obsolete Identifiers:	NCT00006139
Other Study ID Numbers:	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
Study First Received:	August 8, 2000
Results First Received:	June 9, 2009
Last Updated:	January 12, 2010
Health Authority:	United States: Food and Drug Administration