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Phase 3
18 Years
Not Enrolling
Hepatitis C, Hepatitis C, Chronic

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Trial Information

Inclusion Criteria

Inclusion criteria:

- Signed written informed consent.

- Age over 18 years old.

- Presence of HCV RNA measured by qualitative PCR.

- Nonresponder to a previous course of therapy with either IFN alone or IFN plus
ribavirin. The patient must have been treated for at least 3 months (12 weeks).

- Washout period of at least 6 months from previous therapy with IFN alone or IFN plus

- Liver biopsy consistent with cirrhosis or progression to cirrhosis (METAVIR fibrosis
score 3 to 4) due to chronic hepatitis C within the last 12 months before treatment
starts, and at least 6 months after the end of the prior failed therapy.

- Cirrhosis classified as Child-Pugh "A" (no more than 6 points).

- Compensated liver disease with prothrombin time prolonged less than 3 seconds over
control, total bilirubin < 2 mg/dl, and no history of hepatic encephalopathy,
bleeding varices or a history of detection of stigmata of recent bleeding on existing
varices or ascites.

- Ultrasound, CT scan, or MRI of the liver within 3 months of entry negative for HCC.

- Hematocrit > 30%, platelet count > 75,000, WBC > 2,500, and absolute neutrophil cell
count > 1,500.

- Adequate renal function as demonstrated by serum creatinine level < 2.0 mg/dl.

- Normal TSH or adequately controlled thyroid function.

- If the patient is a woman, she is using a definitive method of birth control in
consultation with her physician, or is surgically sterile, or post-menopausal.

Exclusion criteria:

- Use of systemic corticosteroids within 6 months of entry.

- Evidence of drug-induced liver injury.

- Current use of any drug known to have or suspected of having therapeutic activity in
hepatitis C, or any immunosuppressive drug (including corticosteroids).

- Evidence of any other liver disease including hepatitis B, hepatitis delta, alcoholic
liver disease, primary biliary cirrhosis, sclerosing cholangitis, autoimmune
hepatitis, hemochromatosis, alpha 1-antitrypsin deficiency, or Wilson's disease.

- Alpha-fetoprotein > 200 ng/mL.

- Child-Pugh "B" or "C" cirrhosis (score of 7 or more points), either currently or at
any occasion in the past.

- Decompensated liver disease based on a history of hepatic encephalopathy, bleeding
varices or a history of detection of stigmata of recent bleeding on existing varices,
or ascites.

- HIV infection diagnosed by HIV seropositivity and confirmed by Western blot.

- Concomitant or prior history of malignancy other than curatively treated skin cancer
or surgically cured in situ carcinoma of the cervix.

- Active infectious process other than HCV that is not of a self-limited nature.

- Rheumatoid arthritis or other autoimmune disease (serum ANA > 1:160.).

- Pregnancy as documented by a urine pregnancy test.

- Alcohol or intravenous drug abuse within the previous 1 year.

- Chronic use of methadone.

- Patients who are poor medical risk or who have any non-malignant systemic disease
that, in the opinion of the investigator, would make it unlikely that the patient
could complete the protocol.

- Patients with a history of severe depression that required either hospitalization or
electroshock therapy; or depression associated with suicide attempt.

- Patients with significant pre-existing cardiac or pulmonary disease.

- Recipients of transplants.

- Patients with uncontrolled seizure disorder.

- Any indication that the patient would not comply with the conditions of the study

- Previous treatment with thymosin alpha 1.

- Patients with known hypersensitivity to IFN a.

- Simultaneous participation in another investigational drug study, or participation in
any clinical trial involving investigational drugs within 3 months of study entry.

- Family history of intracerebral hemorrhage.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


United States: Food and Drug Administration

Study ID:




Start Date:

May 2002

Completion Date:

Related Keywords:

  • Hepatitis C
  • Hepatitis C, Chronic
  • hepatitis C
  • hepatitis C, chronic
  • cirrhosis, liver
  • Hepatitis
  • Hepatitis A
  • Hepatitis C
  • Hepatitis C, Chronic



Baylor College of Medicine Houston, Texas  77030
Johns Hopkins University Baltimore, Maryland  21205
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
Medical University of South Carolina Charleston, South Carolina  29425-0721
Loma Linda University Medical Center Loma Linda, California  92354
North Shore University Hospital Manhasset, New York  11030
Scripps Clinic La Jolla, California  92037
William Beaumont Hospital Royal Oak, Michigan  48073
Mayo Clinic Jacksonville, Florida  32224
Huntington Memorial Hospital Pasadena, California  91109-7013
Washington Hospital Center Washington, District of Columbia  20010
Advanced Clinical Research Institute Anaheim, California  92801
Wisconsin Center for Advanced Research Milwaukee, Wisconsin  53207
University of Pennsylvania Philadelphia, Pennsylvania  19104
Duke University Medical Center Durham, North Carolina  27710
Oregon Health Sciences University Portland, Oregon  
University of Florida Gainesville, Florida  32610-0277
Albert Einstein Medical Center Philadelphia, Pennsylvania  19141
McGuire DVAMC Richmond, Virginia  23249
California Pacific Medical Center San Francisco, California  94115
University of Louisville Louisville, Kentucky  40202
University of Alabama - Knollwood Physician's Group Mobile, Alabama  
Mayo Clinic Scottsdale, Arizona  
Gastroenterology Associates of East Bay Medical Group Berkeley, California  
Kaiser Permanente Sacramento, California  
University of California, Davis Medical Center Sacramento, California  
San Mateo Medical Center San Mateo, California  
Arapahoe Gastroenterology Littleton, Colorado  
University Of Miami Center for Liver Diseases Miami, Florida  
Digestive Healthcare of Georgia Atlanta, Georgia  
Center for Digestive and Liver Health Savannah, Georgia  
Idaho Gastroenterology Associates Meridian, Idaho  
University of Chicago Hospital & Clinic Chicago, Illinois  
LSU Healthcare Network New Orleans, Louisiana  
Chevy Chase Clinical Research Chevy Chase, Maryland  
Endoscopic Microsurgery Associates Towson, Maryland  
New England Medical Center Boston, Massachusetts  
Mississippi Gastrointestinal Associates Jackson, Mississippi  
VAMC Kansas City, Missouri  
Bradley Freilich MD, LLC Kansas City, Missouri  
VA Harbor HealthCare System New York, New York  
NYU Gastroenterology & Hepatology New York, New York  
Carolinas Center for Liver Disease Charlotte, North Carolina  
University of Cincinnati College of Medicine Cincinnati, Ohio  
Metro Health Medical Ctr. Cleveland, Ohio  
The Cleveland Clinic Foundation Cleveland, Ohio  
Jefferson University Physicians Philadelphia, Pennsylvania  
Advanced Clinical Research Providence, Rhode Island  
University of Tennessee Gastroenterology Memphis, Tennessee  
Austin Gastroenterology PA Austin, Texas  
Baylor University Medical Ctr. Dallas, Texas  
Baylor, VAMC Houston, Texas  
Metropolitan Research Fairfax, Virginia