Long-term Follow-up of HALT-C Sustained Virological Responders

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00825877
First received: January 17, 2009
Last updated: February 19, 2014
Last verified: June 2012
  Purpose

The Hepatitis C Antiviral Long-term Treatment against Cirrhosis (HALT-C) trial is a multicenter clinical trial conducted to assess the effects of long-term antiviral drug therapy on the progression of liver disease in patients who have advanced chronic hepatitis C and have not responded to prior therapies. Chronic hepatitis C is a long-lasting viral infection affecting the liver that may lead to permanent liver damage and cirrhosis (replacement of healthy liver cells by scar tissue). If left untreated, a proportion of patients with chronic hepatitis C will be at risk for complications of liver disease. The drug therapy in the HALT-C trial was designed to clear the hepatitis C virus from the patient s system in order to prevent or mitigate these potential complications. The purpose of this research is to determine if patients with chronic hepatitis C who experienced clearance of hepatitis C virus (known as a sustained virologic response, or SVR) during the HALT-C trial have developed any complications of their liver disease.

This study will include 180 subjects who participated in the initial phase of the HALT-C trial and experienced an SVR. The participants will visit the National Institutes of Health for an in-person study visit.

During the visit, patients will have blood drawn for lab tests to monitor the progress of their liver disease, and may be asked to undergo an ultrasound examination of the liver to detect any abnormalities that may be attributed to liver cancer. Patients will also answer questions about their medical history particularly any outcomes or events related to their hepatitis C that have occurred since the HALT-C trial and may be asked to sign a release of information to allow researchers to obtain medical records from other clinics or physicians where they have received treatment.


Condition
Hepatitis C
Hepatocellular Carcinoma
Ascites
Variceal Hemorrhage
Death

Study Type: Observational
Official Title: Long-Term Follow-Up of HALT-C Sustained Virologic Responders

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Enrollment: 4
Study Start Date: January 2009
Estimated Study Completion Date: June 2012
Detailed Description:

Subjects who have achieved a sustained virologic response during their participation in the multicentered HALT-C clinical trial for treatment of chronic hepatitis C are being invited to return for a single clinic visit to assess whether any decompensation events (e.g. ascites, varicela hemorrhage, hepatic encephalopathy) or hepatocellular cancer has occurred. Subjects able and willing to return to the NIH will undergo standard clinical examinations, questionnaires and an ultrasound examination of the liver, to assess the status of their hepatitis C. Data will be pooled from all of the 10 clinical centers, analyzed and compared to an age and gender matched control group of nonresponder subjects who participated in the HALT-C Trial. A data coordinating center (New England Research Institutes) will conduct the data analysis. This will be a descriptive natural history study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Patients who developed a virological response at week 20 of the HALT-C study.

EXCLUSION CRITERIA:

None

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00825877

Locations
United States, California
University of Southern California
Los Angeles, California, United States, 90033
University of California, Irvine Medical Center
Orange, California, United States, 92668
United States, Connecticut
Univ. of Connecticut Health Center
Farmington, Connecticut, United States, 06030
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
University of Massachusetts
Worcester, Massachusetts, United States, 01655-0331
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109-0624
United States, Missouri
St. Louis University
St. Louis, Missouri, United States, 63104
United States, Texas
University of Texas, Dallas
Dallas, Texas, United States, 75216
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23284
Sponsors and Collaborators
Investigators
Principal Investigator: Marc G Ghany, M.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00825877     History of Changes
Other Study ID Numbers: 090067, 09-DK-0067
Study First Received: January 17, 2009
Last Updated: February 19, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Hepatitis C
Sustained Virological Response
HALT-C
Peginterferon and Ribavirin
HCV RNA

Additional relevant MeSH terms:
Hepatitis
Hepatitis C
Carcinoma, Hepatocellular
Hemorrhage
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Pathologic Processes

ClinicalTrials.gov processed this record on October 01, 2014