Thymosin Plus PEG-Interferon in Non-Cirrhotic Hepatitis C Patients Who Did Not Respond to Interferon or Interferon Plus Ribavirin

January 8, 2008 updated by: SciClone Pharmaceuticals

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

500

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SciClone Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Study Registration Dates

First Submitted

June 18, 2002

First Submitted That Met QC Criteria

July 3, 2002

First Posted (Estimate)

July 4, 2002

Study Record Updates

Last Update Posted (Estimate)

January 15, 2008

Last Update Submitted That Met QC Criteria

January 8, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ta1-CHC-2K0803a

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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