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
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 3 |
| 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
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:
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:
|
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
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 |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
|
liver disease hepatitis c virus antiviral agent cirrhosis |
Additional relevant MeSH terms:
|
Fibrosis Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis C Liver Cirrhosis Hepatitis C, Chronic Pathologic Processes Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections |
RNA Virus Infections Flaviviridae Infections Antiviral Agents Ribavirin Peginterferon alfa-2a Interferon-alpha Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013