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

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

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/ 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:

Lindsay KL, Morishima C, Wright EC, Dienstag JL, Shiffman ML, Everson GT, Lok AS, Bonkovsky HL, Lee WM, Morgan TR, Ghany MG; HALT-C Trial. Blunted cytopenias and weight loss: new correlates of virologic null response to re-treatment of chronic hepatitis C. Clin Gastroenterol Hepatol. 2008 Feb;6(2):234-41.

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

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