Thymosin Plus PEG-Interferon in Hepatitis C Patients With Cirrhosis Who Did Not Respond to Interferon or Interferon Plus Ribavirin
NCT ID: NCT00039962
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
2002-05-31
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 with early cirrhosis or progression to 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
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 3 months (12 weeks).
* Washout period of at least 6 months from previous therapy with IFN alone or IFN plus Ribavirin.
* 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
* 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 protocol.
* 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.
18 Years
ALL
No
Sponsors
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SciClone Pharmaceuticals
INDUSTRY
Locations
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University of Alabama - Knollwood Physician's Group
Mobile, Alabama, United States
Mayo Clinic
Scottsdale, Arizona, United States
Advanced Clinical Research Institute
Anaheim, California, United States
Gastroenterology Associates of East Bay Medical Group
Berkeley, California, United States
Scripps Clinic
La Jolla, California, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Huntington Memorial Hospital
Pasadena, California, United States
Kaiser Permanente
Sacramento, California, United States
University of California, Davis Medical Center
Sacramento, California, United States
California Pacific Medical Center
San Francisco, California, United States
San Mateo Medical Center
San Mateo, California, United States
Kaiser Permanente
Santa Clara, California, United States
Arapahoe Gastroenterology
Littleton, Colorado, 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
Digestive Healthcare of Georgia
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
University of Louisville
Louisville, Kentucky, United States
LSU Healthcare Network
New Orleans, Louisiana, United States
Johns Hopkins University
Baltimore, Maryland, United States
Chevy Chase Clinical Research
Chevy Chase, Maryland, United States
Endoscopic Microsurgery Associates
Towson, Maryland, United States
New England Medical Center
Boston, Massachusetts, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Mississippi Gastrointestinal Associates
Jackson, Mississippi, United States
Bradley Freilich MD, LLC
Kansas City, Missouri, United States
VAMC
Kansas City, Missouri, United States
North Shore University Hospital
Manhasset, New York, United States
NYU Gastroenterology & Hepatology
New York, New York, United States
VA Harbor HealthCare System
New York, New York, United States
Carolinas Center for Liver Disease
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 Ctr.
Cleveland, Ohio, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Oregon Health Sciences University
Portland, Oregon, United States
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States
Jefferson University Physicians
Philadelphia, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Advanced Clinical Research
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
University of Tennessee Gastroenterology
Memphis, Tennessee, United States
Austin Gastroenterology PA
Austin, Texas, United States
Baylor University Medical Ctr.
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Baylor, VAMC
Houston, Texas, United States
Metropolitan Research
Fairfax, Virginia, United States
McGuire DVAMC
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-2K0804
Identifier Type: -
Identifier Source: org_study_id
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