Thymosin Plus PEG-Interferon in Non-Cirrhotic Hepatitis C Patients Who Did Not Respond to Interferon or Interferon Plus Ribavirin
NCT ID: NCT00040027
Last Updated: 2008-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
500 participants
INTERVENTIONAL
2002-04-30
Brief Summary
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This is a randomized, double-blinded, multicenter trial to determine the effectiveness of thymosin alpha 1 (thymalfasin) 1.6 mg twice weekly plus PEGinterferon alfa-2a 180 ug/wk compared to placebo plus PEGinterferon alfa-2a in adults with chronic hepatitis C without cirrhosis who are non-responders to previous treatment with interferon or interferon plus ribavirin. The definition of non-response requires a positive HCV RNA test at the end of a course of at least 12 weeks of therapy. Patients will receive treatment for 12 months, and will be followed-up for a further 6 months after the end of therapy.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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thymalfasin (thymosin alpha 1) + PEGinterferon alfa-2a
placebo + PEGinterferon alfa-2a
Eligibility Criteria
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Inclusion Criteria
* 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 Ribavirin.
* 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
* 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 endoscopy.
* 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 protocol.
* 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.
18 Years
ALL
No
Sponsors
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SciClone Pharmaceuticals
INDUSTRY
Locations
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University of Alabama - Knollwood Physician's Group Bldg.
Mobile, Alabama, United States
Mayo Clinic
Scottsdale, Arizona, United States
Gastroenterology Associates of East Bay Medical Group
Berkeley, California, United States
Scripps Clinic
La Jolla, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
California Pacific Medical Center
San Francisco, California, United States
Veterans Administration Medical Center GI Section (111B)
San Francisco, California, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
University of Florida
Gainesville, Florida, United States
Mayo Clinic
Jacksonville, Florida, United States
University of Miami Center for Liver Diseases
Miami, Florida, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States
Center for Digestive and Liver Health
Savannah, Georgia, United States
Idaho Gastroenterology Associates
Meridian, Idaho, United States
University of Chicago Hospital & Clinic
Chicago, Illinois, United States
Hepatitis C Treatment Centers, Inc.
Louisville, Kentucky, United States
Liver Research Center - University of Louisville
Louisville, Kentucky, United States
Louisiana State University Healthcare Network
New Orleans, Louisiana, United States
Johns Hopkins University
Baltimore, Maryland, United States
Chevy Chase Clinical Research
Chevy Chase, Maryland, United States
New England Medical Center
Boston, Massachusetts, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Mississippi Gastrointestinal Associates
Jackson, Mississippi, United States
VAMC
Kansas City, Missouri, United States
Saint Louis University Hospital
St Louis, Missouri, United States
North Shore University Hospital
Manhasset, New York, United States
Bronx VA Medical Center
New York, New York, United States
NY VAMC
New York, New York, United States
NYU Hospitals Center
New York, New York, United States
Carolinas Center for Liver Diseases
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Cincinnati - College of Medicine
Cincinnati, Ohio, United States
Metro Health Medical Center, GI Division
Cleveland, Ohio, United States
Oregon Health Sciences University
Portland, Oregon, United States
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
Roger Williams Medical Center
Providence, Rhode Island, United States
GI Center MidSouth
Memphis, Tennessee, United States
University of Tennessee Gastroenterology
Memphis, Tennessee, United States
Baylor University Medical Center
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Baylor, VAMC
Houston, Texas, United States
Metropolitan Research
Fairfax, Virginia, United States
McGuire Research Institute
Richmond, Virginia, United States
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, United States
Ponce School of Medicine
Ponce, , Puerto Rico
Fundacion de Investigacion de Diego
Santurce, , Puerto Rico
Countries
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Other Identifiers
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Ta1-CHC-2K0803a
Identifier Type: -
Identifier Source: org_study_id
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