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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 12 weeks.

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

- Liver biopsy consistent with chronic hepatitis C within the last 12 months before
treatment starts, and at least 6 months after the end of the prior failed therapy.

- No clinical or histological evidence of cirrhosis (METAVIR fibrosis score 0 to 3).

- Compensated liver disease with prothrombin time prolonged less than 3 seconds over
control, serum albumin stable and within normal limits, total bilirubin < 2 mg/dl,
and no history of hepatic encephalopathy, esophageal varices or ascites.

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

- Hematocrit > 30%, platelet count > 100 x 109/L, WBC > 3 x 109/L, and
polymorphonuclear white cell count > 1.5 x 109/L.

- 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.

- Current use of any drug known to be hepatotoxic, any drug (other than the study
drugs) known to have or suspected of having therapeutic activity in hepatitis C or of
any immunosuppressive drug (including corticosteroids).

- Any other liver disease including hepatitis B, hepatitis delta, alcoholic liver
disease, drug-induced liver injury, primary biliary cirrhosis, sclerosing
cholangitis, autoimmune hepatitis, hemochromatosis, alpha 1-antitrypsin deficiency,
or Wilson's disease.

- Alpha-fetoprotein > 200 ng/mL.

- Current or past diagnosis of cirrhosis.

- Evidence of portal hypertension either by Doppler ultrasonography or gastrointestinal

- Decompensated liver disease based on a history of hepatic encephalopathy, esophageal
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 (eg. TB
or AIDS).

- 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.

- 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 IFNa.

- Simultaneous participation in another investigational drug study, or participation in
any clinical trial involving investigational drugs with 3 months before 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:

April 2002

Completion Date:

Related Keywords:

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



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Liver Research Center - University of Louisville Louisville, Kentucky  
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NY VAMC New York, New York  
NYU Hospitals Center New York, New York  
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Carolinas Center for Liver Diseases Charlotte, North Carolina  
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