The objective is to compare the safety and efficacy of the following three treatment regimens in previously untreated adult subjects with chronic hepatitis C infected with Genotype 1: (1) PEG-Intron 1.5 µg/kg/wk in combination with weight based REBETOL (800-1400 mg/day); (2) PEG-Intron 1µg/kg/wk in combination with weight based REBETOL (800-1400 mg/day); and (3) PEGASYS 180 µg/wk plus COPEGUS 1000-1200 mg/day.

Condition	Treatment or Intervention	Phase
Chronic Hepatitis C	Drug: PEG-Intron Plus REBETOL  Drug: PEGASYS Plus COPEGUS	Phase III

PEG-Intron Dose: Screening 2 Weight 40-50 kg Volume to Inject (mL)0.22; Screening 2 Weight 51-60 kg Volume to Inject (mL)0.28; Screening 2 Weight 61-75 kg Volume to Inject (mL)0.33; Screening 2 Weight 76-85 kg Volume to Inject (mL)0.41; Screening 2 Weight 86-104 kg Volume to Inject (mL)0.48; Screening 2 Weight 105-125 kg Volume to Inject (mL)0.58 from two vials

REBETOL Dosage (for Use With PEG-INTRON): Screening 2 Weight 40-60 kg Daily Dose 800mg; Screening 2 Weight >65-85 kg Daily Dose 1000mg; Screening 2 Weight >85-105 kg Daily Dose 1200mg; Screening 2 Weight >105-125 kg Daily Dose 1400mg

The PEGASYS dose of 1 mL (180 µg) will be administered once weekly subcutaneously on the same day of the week

COPEGUS Dosage (for Use With PEGASYS): Screening 2 Weight <75kg Daily Dose 1000mg; Screening 2 Weight > or = 75kg Daily Dose 1200mg

NOTE: Double Blind for PEG-Intron; Open Label for REBETOL, PEGASYS and COPEGUS

Ages Eligible for Study:  18 Years   -   70 Years,  Genders Eligible for Study:  Both

Criteria

INCLUSION CRITERIA:

• Previously untreated adults with chronic hepatitis C (HCV RNA qPCR plasma positive)
• Individuals with HCV genotype 1 (mixed 1a/1b is acceptable)
• Compensated liver disease
• No significant co-existing psychiatric disease
• Historic liver biopsy slides available
• Adults aged 18-70
• Individuals weighing 88-275 pounds (40-125 kg)
• Free from substance abuse for past 2 years
• Those suffering from diabetes and/or hypertension must have normal eye exams and retinal photographs (these will be done as part of the study before hepatitis C treatment is given)
• Patients and partners of patients willing to use adequate contraception during the course of the study
• Hematology laboratory results of: * Hemoglobin (HGB) > 12 g/dL for females or > 13g/dL for males * White Blood Cell Count (WBC) > 3,000 mm3 * Neutrophils > 1,500 mm3 * Platelets > 80,000 mm3
• Chemistry laboratory results of: * Normal Thyroid Stimulating Hormone (TSH), albumin, creatinine, and direct bilirubin * Antinuclear antibody (ANA) < 1:320 * Fasting Glucose 70-140 mg/dL Note: If glucose levels are between 116-140 mg/dL or an individual has diabetes, HbA1C must be < 8.5

EXCLUSION CRITERIA:

• Previous hepatitis C treatment
• Pregnant women or partners of pregnant women
• Patients or partners of patients who intend to become pregnant any time during the 48 weeks
• Women who are breast feeding
• People with liver disease not caused by hepatitis C
• Individuals infected with the hepatitis B virus and/or human immunodeficiency virus (HIV)
• Patients with a history of liver cancer (hepatocellular carcinoma)
• Known blood disorders such as hemoglobinopathy, coagulopathy, or G6PD deficiency
• Body organ transplant
• Any known or suspected cancer within the past 5 years
• Individuals who currently use EPO, G-CSF and/or GM-CSF
• Those having a history of or active clinical gout
• People who have chronic pulmonary disease
• Individuals who have a medical condition that would likely require systemic steroids
• Those with a history of central nervous system (CNS trauma) or seizure disorders
• Current or previous use of lithium or antipsychotic drugs
• Individuals who currently have or show signs of moderate to severe depression
• Patients with clinically significant electrocardiogram (ECG) abnormalities
• Individuals with serious heart problems such as those who have had a heart attack, high blood pressure, or other heart problems
• Patients that weigh > 231-275 pounds (105-125 kg) AND have a body mass index (BMI) > 30 AND have 3 or more of the risk factors below: (a) Strong family history of coronary heart disease (CHD) which includes 2 or more first-degree relatives with CHD or family history of early CHD at age < 55 for male relatives or < 65 for female relatives (b) People with abnormal total cholesterol and/or sub fractions (uncontrolled hypercholesterolemia) (c) Diabetes (d) Hypertension (e) Smoking

Alabama
      University of South AL, Mobile,  Alabama,  36693,  United States; Recruiting
      University of AL at Birmingham Liver Center, Birmingham,  Alabama,  35294,  United States; Recruiting
Arizona
      University of Arizona Liver Research Institute, Tucson,  Arizona,  85724,  United States; Recruiting
California
      Kaiser Permanente, Sacramento,  California,  95825,  United States; Recruiting
      VA Medical Center - 11, Long Beach,  California,  90822,  United States; Recruiting
      SCPMG, San Diego,  California,  92173,  United States; Recruiting
      Cedars-Sinai Medical Center, Los Angeles,  California,  90048,  United States; Recruiting
      University of California Irvine Medical Center, Orange,  California,  92868,  United States; Recruiting
      University of California, Davis Sacremento Medical Center (UCDMC), Sacramento,  California,  95817,  United States; Recruiting
      Kaiser Permanente, Santa Clara,  California,  95051,  United States; Recruiting
      San Francisco General Hospital, San Francisco,  California,  94110,  United States; Recruiting
Colorado
      South Denver Gastroenterology, PC, Englewood,  Colorado,  80110,  United States; Recruiting
Connecticut
      Connecticut Gastroenterology & Medical Associates, Hartford,  Connecticut,  06106,  United States; Recruiting
      GI Division UConn Health Center, Farmington,  Connecticut,  06030,  United States; Recruiting
Florida
      South Florida Center of Gastroenterology, P.A., Wellington,  Florida,  33414,  United States; Recruiting
      Bach and Godofsky, MD PA, Bradenton,  Florida,  34205,  United States; Recruiting
      Miami Research Associates, Miami,  Florida,  33173,  United States; Recruiting
      University of Miami Center for Liver Diseases, Miami,  Florida,  33136,  United States; Recruiting
Georgia
      Digestive Healthcare of Georgia, PC, Atlanta,  Georgia,  30309,  United States; Recruiting
      Northwest Georgia Gastroenterology Associates, Marietta,  Georgia,  30060,  United States; Recruiting
      Kaiser Permanente, Atlanta,  Georgia,  30328,  United States; Recruiting
Illinois
      Northwestern University, Chicago,  Illinois,  60611,  United States; Recruiting
      Digestive Health Services, Downers Grove,  Illinois,  60515,  United States; Recruiting
Indiana
      Indiana University School of Medicine, Indianapolis,  Indiana,  46202,  United States; Recruiting
Kentucky
      University of Kentucky, Lexington,  Kentucky,  40536,  United States; Recruiting
      University of Louisville, HSC, Louisville,  Kentucky,  40202,  United States; Recruiting
Louisiana
      LSU Health Sciences Center, Shreveport,  Louisiana,  71130,  United States; Recruiting
      Ochsner Clinic Foundation, New Orleans,  Louisiana,  70121,  United States; Recruiting
      Louisiana State University, New Orleans,  Louisiana,  70115,  United States; Recruiting
      Tulane University Health Science Center, New Orleans,  Louisiana,  70112,  United States; Recruiting
      Louisiana State University, Health Sciences Center, Baton Rouge,  Louisiana,  70805,  United States; Recruiting
Maine
      Hepatitis Treatment Service, Maine Medical Center, Portland,  Maine,  04102,  United States; Recruiting
Maryland
      Johns Hopkins University, Baltimore,  Maryland,  21287,  United States; Recruiting
      University of Maryland School of Medicine, Baltimore,  Maryland,  21201,  United States; Recruiting
      Digestive Disease Associates, PA, Baltimore,  Maryland,  21229,  United States; Recruiting
Massachusetts
      Lahey Clinic Medical Center, Burlington,  Massachusetts,  01805,  United States; Recruiting
      Boston Medical Center, Boston,  Massachusetts,  02118,  United States; Recruiting
      Massachusetts General Hospital, Boston,  Massachusetts,  02114,  United States; Recruiting
Michigan
      Henry Ford Hospital, Detroit,  Michigan,  48202,  United States; Recruiting
      William Beaumont Hospital, Royal Oaks,  Michigan,  48073,  United States; Recruiting
Minnesota
      Hennepin County Medical Center, Minneapolis,  Minnesota,  55415,  United States; Recruiting
      Minnesota Clinical Research Center, Plymouth,  Minnesota,  55443,  United States; Recruiting
      VA Medical Center, Minneapolis,  Minnesota,  55417,  United States; Recruiting
Missouri
      VA Medical Center, Kansas City,  Missouri,  64128,  United States; Recruiting
      St. Louis University, St. Louis,  Missouri,  36110,  United States; Recruiting
      University of Missouri-Columbia, Columbia,  Missouri,  65212,  United States; Recruiting
      Bradley Freilich, M.D., LLC, Kansas City,  Missouri,  64131,  United States; Recruiting
      Washington University School of Medicine, St. Louis,  Missouri,  63110,  United States; Recruiting
Nebraska
      Gastroenterology Specialists, PC, Lincoln,  Nebraska,  68503,  United States; Recruiting
New Jersey
      Affiliates in Gastroenterology, PA, Florham Park,  New Jersey,  07932,  United States; Recruiting
New York
      North Shore University Hospital, Manhasset,  New York,  11030,  United States; Recruiting
      University Hospital-SUNY Upstate Medical University, Syracuse,  New York,  13210,  United States; Recruiting
      Bronx VA Medical Center, Bronx,  New York,  10468,  United States; Recruiting
      VA New York Harbor Healthcare System, New York,  New York,  10010,  United States; Recruiting
      Weill Medical College of Cornell University, New York,  New York,  10021,  United States; Recruiting
      Beth Israel Medical Center, New York,  New York,  10003,  United States; Recruiting
      New York Medical College, Valhalla,  New York,  10595,  United States; Recruiting
      Huntington Medical Group, Huntington,  New York,  11746,  United States; Recruiting
North Carolina
      Duke University Medical School, Durham,  North Carolina,  27710,  United States; Recruiting
      Carolina Center for Liver Disease, Charlotte,  North Carolina,  28203,  United States; Recruiting
Ohio
      University of Cincinnati, Cincinnati,  Ohio,  45267,  United States; Recruiting
      Summa Health System, Akron,  Ohio,  44304,  United States; Recruiting
      University Hospitals of Cleveland, Cleveland,  Ohio,  44106,  United States; Recruiting
Oregon
      Oregon Health Sciences University, Portland,  Oregon,  97201,  United States; Recruiting
Pennsylvania
      Regional Gastroenterology Associates of Lancaster, Lancaster,  Pennsylvania,  17603,  United States; Recruiting
      Thomas Jefferson University, Philadelphia,  Pennsylvania,  19107,  United States; Recruiting
      Pennsylvania Hospital, Philadelphia,  Pennsylvania,  19107,  United States; Recruiting
      Penn State University Milton S. Hershey Medical Center, Hershey,  Pennsylvania,  17033,  United States; Recruiting
      Temple University Hospital, Philadelphia,  Pennsylvania,  19140,  United States; Recruiting
      Albert Einstein Medical Center, Philadelphia,  Pennsylvania,  19141,  United States; Recruiting
      University of Pittsburgh Medical Center, Pittsburgh,  Pennsylvania,  15213,  United States; Recruiting
Rhode Island
      University Gastroenterology, Providence,  Rhode Island,  02905,  United States; Recruiting
South Carolina
      Medical University of South Carolina, Charleston,  South Carolina,  29425,  United States; Recruiting
Tennessee
      Premier Quality Research Consultants, Nashville,  Tennessee,  37211,  United States; Recruiting
Texas
      The Liver Institute at Methodist Dallas, Dallas,  Texas,  75208,  United States; Recruiting
      Alamo Medical Research, San Antonio,  Texas,  78215,  United States; Recruiting
      University of Texas, Dallas,  Texas,  75390,  United States; Recruiting
      Liver Specialists of Texas, P.A., Houston,  Texas,  77030,  United States; Recruiting
      Kelsey-Seybold Clinic, Houston,  Texas,  77025,  United States; Recruiting
Utah
      Mountain West Gastroenterology, Salt Lake City,  Utah,  84121,  United States; Recruiting
Vermont
      University Of Vermont, Burlington,  Vermont,  05405,  United States; Recruiting
Virginia
      University of Virginia, Dept. of GI/Hepatology, Charlottesville,  Virginia,  22908,  United States; Recruiting
      Mount Vernon Endoscopy Center, Alexandria,  Virginia,  22306,  United States; Recruiting
      Digestive & Liver Disease Specialists, Norfolk,  Virginia,  23502,  United States; Recruiting
      Medical College Of Virginia, Richmond,  Virginia,  23298,  United States; Recruiting
      Kaiser Permanente Medical Center, Falls Church,  Virginia,  22046,  United States; Recruiting
Wisconsin
      Dean Medical Center, Madison,  Wisconsin,  53715,  United States; Recruiting
      Froedtert Memorial Lutheran Hospital, Milwaukee,  Wisconsin,  53226,  United States; Recruiting
      University of Wisconsin Hospital and Clinics, Madison,  Wisconsin,  53792-5124,  United States; Recruiting

Study ID Numbers:  P03471; 2552898
Record last reviewed:  October 2004
Record first received:  April 20, 2004
ClinicalTrials.gov Identifier:  NCT00081770
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10