Data Collection for the HALT-C Main Trial

  1. Medical History
  2. Baseline History
    1. Determine source and duration of infection
    2. Past interferon treatment
  3. Current Medications
  4. Physical Exam
  5. CTP Score
  6. Ultrasound examination of the liver
  7. Endoscopy - Baseline, M24, M48
  8. Laboratory Tests
    1. CBC with differential
    2. Fasting Serum Chemistries
    3. Serum Uric Acid
    4. Liver Chemistries
      • AST
      • ALT
      • Alkaline phosphatase
      • Total bilirubin
      • Direct bilirubin
      • Albumin
      • Globulin or Total Protein
      • GGTP
    5. Prothrombin Time (INR)
    6. TSH
    7. AFP
    8. Urinalysis (heme & protein)
    9. HIV (Screening, M48)
    10. Other Biochemical tests
      • Total cholesterol
      • C-reactive protein (CRP)
      • Transferrin
      • HDL Cholesterol
      • Rheumatoid factor (RF)
      • Total bile acids
      • Unsaturated iron binding capacity (UIBC)
    11. Hepatitis C testing
      • HCV RNA
      • HCV Genotype
  9. Symptoms & Life Events
    1. Quality of Life (SF-36)
    2. Alcohol Use
    3. Symptoms
    4. Beck Depression Inventory
    5. Life Events
  10. Liver Biopsy - Screening, M24, M48
    1. Fibrosis
    2. Fat
    3. Zone 3 pericellular fibrosis
    4. Inflammation
    5. Hepatocyte dysplasia
    6. Bile duct lesions
    7. Lymphoid follicles
    8. Mallory bodies
    9. Confluent necrosis
    10. Hepatocellular iron grade
  11. Adverse Events and Serious Adverse Events
  12. Clinical Outcomes
    1. Death
    2. Development of hepatocellular carcinoma (definite and presumed)
    3. Sustained increase in the Child-Turcotte-Pugh score to 7 points or higher
    4. Variceal hemorrhage
    5. Ascites
    6. Spontaneous bacterial peritonitis
    7. Hepatic encephalopathy
    8. Liver transplant
  13. Block Food Frequency Questionnaire - Screening and M18
  14. Composite International Diagnostic Interview (CIDI) - Screening

Data Collected for the HALT-C Ancillary Studies

Note: many ancillary studies enrolled a subset of HALT-C patients.

Immunology/Virology (N=367)

  1. CTL
  2. Neutralizing Antibody
  3. Quasispecies
  4. Lymphoproliferation
  5. Replication

Hepatic Steatosis

  1. Glycosylated Hemoglobin (diabetics only) (N=175)
  2. Fasting Insulin (N= 1143)

Serum Fibrosis Markers (N=626)

  1. Serum TGF-B1
  2. PIIINP
  3. TIMP-1
  4. YKL-40
  5. Hyaluronic acid

Cognitive Effects (N=201)

  1. Serum Cortisol
  2. Shipley Institute of Living Scale
  3. Neuropsychiatric Battery
    1. Selective Reminding Test
    2. Continuous Visual Memory Test
    3. Digit Span
    4. Digit Symbol
    5. Serial Digit Learning
    6. Simple Reaction Time
    7. Choice Reaction Time
    8. Trail Making Test A
    9. Trail Making Test B
    10. Finger Tapping Test
    11. Wisconsin Card Sorting Test
    12. Controlled Oral Word Association Test
  4. Composite Int'l Diagnostic Interview (CIDI-12)
  5. Brief Symptom Inventory (BSI)
  6. Serotonin blood level
  7. Years of Education
  8. Occupational Status

Quantitative Liver Function Tests (QLFT) (N=285)

  1. Cholate Kinetics
    1. K elimination
    2. V distribution
    3. IV Clearance
    4. PO Clearance
    5. Shunt Fraction
  2. Antipyrine Clearance
    1. K elimination
    2. V distribution
    3. Clearance
  3. Caffeine Clearance - K elimination
  4. Galactose Clearance - Elimination capacity
    1. Lidocaine/Megx
      • 15 Min - Base
      • 30 Min - Base
  5. SPECT scan
  6. Methionine Breath Test

Risk Factors (all patients)

  1. Physical Activity
  2. Analgesics Medications
  3. Cigarette Smoking History
  4. Current Cigarette Smoking
  5. Hormone Use (female patients only)
  6. Weight History

Iron & HFE Gene Testing

  1. Histopathology (all patients)
  2. Hepatic Iron Concentration (N=140)
  3. Serum Iron (all patients)
  4. HFE Genetic Testing

DCP (all patients)

  1. Des-γ-Carboxy Prothrombin (DCP)

AFP-L3 (all patients)

  1. AFP-L3

Pre-Study Serial Histology (N=753)

  1. Past biopsy data

Genetics Ancillary Studies

  1. DNA from 1262 patients

Bayer TMA (all patients)

  1. HCV RNA test using the TMA assay