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Long-Term Follow-Up of HALT-C Sustained Virologic Responders


N/A
18 Years
N/A
Not Enrolling
Both
Hepatitis C, Hepatocellular Carcinoma, Ascites, Variceal Hemorrhage, Death

Thank you

Trial Information

Long-Term Follow-Up of HALT-C Sustained Virologic Responders


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.

Inclusion Criteria


- INCLUSION CRITERIA:

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

EXCLUSION CRITERIA:

None

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

Francesco S Celi, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

United States: Federal Government

Study ID:

090067

NCT ID:

NCT00825877

Start Date:

January 2009

Completion Date:

June 2012

Related Keywords:

  • Hepatitis C
  • Hepatocellular Carcinoma
  • Ascites
  • Variceal Hemorrhage
  • Death
  • Hepatitis C
  • Sustained Virological Response
  • HALT-C
  • Peginterferon and Ribavirin
  • HCV RNA
  • Ascites
  • Carcinoma
  • Hemorrhage
  • Hepatitis
  • Hepatitis A
  • Hepatitis C
  • Carcinoma, Hepatocellular

Name

Location
National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda, Maryland  20892
University of Michigan Ann Arbor, Michigan  48109-0624
Massachusetts General Hospital Boston, Massachusetts  02114-2617
Univ. of Connecticut Health Center Farmington, Connecticut  06030
Virginia Commonwealth University Richmond, Virginia  
St. Louis University St. Louis, Missouri  63110
University of Southern California Los Angeles, California  90033
University of Massachusetts Worcester, Massachusetts  01655
University of California, Irvine Medical Center Orange, California  92868
University of Texas, Dallas Dallas, Texas  75216