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Hepatitis C Antiviral Long-term Treatment Against Cirrhosis Trial (HALT-C)


Phase 3
18 Years
N/A
Not Enrolling
Both
Chronic Hepatitis C, Cirrhosis, Liver, Fibrosis, Liver, Hepatic Cirrhosis

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Trial Information

Hepatitis C Antiviral Long-term Treatment Against Cirrhosis Trial (HALT-C)


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

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

Outcome Time Frame:

1400 days (3.85 years) post randomization

Safety Issue:

No

Principal Investigator

Gregory T. Everson, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

UCHSC (University of Colorado)

Authority:

United States: Food and Drug Administration

Study ID:

HALT C

NCT ID:

NCT00006164

Start Date:

June 2000

Completion Date:

October 2009

Related Keywords:

  • Chronic Hepatitis C
  • Cirrhosis, Liver
  • Fibrosis, Liver
  • Hepatic Cirrhosis
  • liver disease
  • hepatitis c virus
  • antiviral agent
  • cirrhosis
  • Fibrosis
  • Hepatitis
  • Hepatitis A
  • Hepatitis, Chronic
  • Hepatitis C
  • Liver Cirrhosis
  • Hepatitis C, Chronic

Name

Location
University of Michigan Ann Arbor, Michigan  48109-0624
University of Connecticut Health Center Farmington, Connecticut  06360-7106
Massachusetts General Hospital Boston, Massachusetts  02114-2617
University of California-Irvine/VA Medical Center-Long Beach Long Beach, California  90822
USC School of Medicine Los Angeles, California  90033
UCHSC (University of Colorado) Denver, Colorado  80262
Lds, Niddk, Nih Bethesda, Maryland  20892-1800
UMass Memorial HealthCare, University Campus Worcester, Massachusetts  01655
Saint Louis University St. Louis, Missouri  63104
University of Texas Southwestern - Dallas Dallas, Texas  75390-9195
Medical College of Virginia Richmond, Virginia  23298-0341