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Thymosin Plus PEG-Interferon in Non-Cirrhotic Hepatitis C Patients Who Did Not Respond to Interferon or Interferon Plus Ribavirin
This study has been completed.
First Received: June 18, 2002   Last Updated: January 8, 2008   History of Changes
Sponsor: SciClone Pharmaceuticals
Information provided by: SciClone Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00040027
  Purpose

Chronic hepatitis C infection is one of the leading causes of chronic liver disease in the United States. Approximately one-third of patients with hepatitis C infection develop cirrhosis of the liver, which can lead to liver failure or liver cancer. The current treatment for hepatitis C infection in previously untreated patients is successful in only about half of patients. There is no established therapy for non-responders.

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.


Condition Intervention Phase
Hepatitis C
Hepatitis C, Chronic
Drug: thymalfasin (thymosin alpha 1) + PEGinterferon alfa-2a
Drug: placebo + PEGinterferon alfa-2a
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Resource links provided by NLM:


Further study details as provided by SciClone Pharmaceuticals:

Estimated Enrollment: 500
Study Start Date: April 2002
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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:

  • 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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00040027

  Hide Study Locations
Locations
United States, Alabama
University of Alabama - Knollwood Physician's Group Bldg.
Mobile, Alabama, United States
United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States
United States, California
California Pacific Medical Center
San Francisco, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Veterans Administration Medical Center GI Section (111B)
San Francisco, California, United States
Scripps Clinic
La Jolla, California, United States
Gastroenterology Associates of East Bay Medical Group
Berkeley, California, United States
United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States
Washington Hospital Center
Washington, District of Columbia, United States
United States, Florida
University of Florida
Gainesville, Florida, United States
University of Miami Center for Liver Diseases
Miami, Florida, United States
Mayo Clinic
Jacksonville, Florida, United States
United States, Georgia
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States
Center for Digestive and Liver Health
Savannah, Georgia, United States
United States, Idaho
Idaho Gastroenterology Associates
Meridian, Idaho, United States
United States, Illinois
University of Chicago Hospital & Clinic
Chicago, Illinois, United States
United States, Kentucky
Liver Research Center - University of Louisville
Louisville, Kentucky, United States
Hepatitis C Treatment Centers, Inc.
Louisville, Kentucky, United States
United States, Louisiana
Louisiana State University Healthcare Network
New Orleans, Louisiana, United States
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States
Chevy Chase Clinical Research
Chevy Chase, Maryland, United States
United States, Massachusetts
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States
New England Medical Center
Boston, Massachusetts, United States
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States
United States, Mississippi
Mississippi Gastrointestinal Associates
Jackson, Mississippi, United States
United States, Missouri
Saint Louis University Hospital
SainT Louis, Missouri, United States
VAMC
Kansas City, Missouri, United States
United States, New York
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
North Shore University Hospital
Manhasset, New York, United States
United States, North Carolina
Carolinas Center for Liver Diseases
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
United States, Ohio
Metro Health Medical Center, GI Division
Cleveland, Ohio, United States
University of Cincinnati - College of Medicine
Cincinnati, Ohio, United States
United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States
United States, Pennsylvania
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
United States, Rhode Island
Roger Williams Medical Center
Providence, Rhode Island, United States
United States, Tennessee
GI Center MidSouth
Memphis, Tennessee, United States
University of Tennessee Gastroenterology
Memphis, Tennessee, United States
United States, Texas
Baylor University Medical Center
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Baylor, VAMC
Houston, Texas, United States
United States, Virginia
McGuire Research Institute
Richmond, Virginia, United States
Metropolitan Research
Fairfax, Virginia, United States
United States, Wisconsin
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, United States
Puerto Rico
Fundacion de Investigacion de Diego
Santurce, Puerto Rico
Ponce School of Medicine
Ponce, Puerto Rico
Sponsors and Collaborators
SciClone Pharmaceuticals
  More Information

No publications provided

Study ID Numbers: Ta1-CHC-2K0803a
Study First Received: June 18, 2002
Last Updated: January 8, 2008
ClinicalTrials.gov Identifier: NCT00040027     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by SciClone Pharmaceuticals:
hepatitis C
hepatitis C, chronic

Additional relevant MeSH terms:
Anti-Infective Agents
Liver Diseases
Hepatitis, Chronic
Flaviviridae Infections
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Hepatitis, Viral, Human
Therapeutic Uses
Hepatitis C
Angiogenesis Modulating Agents
Growth Inhibitors
RNA Virus Infections
Growth Substances
Adjuvants, Immunologic
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Virus Diseases
Hepatitis
Thymalfasin
Digestive System Diseases
Peginterferon alfa-2a
Interferon Alfa-2a
Hepatitis C, Chronic

ClinicalTrials.gov processed this record on November 27, 2009