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Thymosin Plus PEG-Interferon in Non-Cirrhotic Hepatitis C Patients Who Did Not Respond to Interferon or Interferon Plus Ribavirin Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Thymosin Plus PEG-Interferon in Non-Cirrhotic Hepatitis C Patients Who Did Not Respond to Interferon or Interferon Plus Ribavirin conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Thymosin Plus PEG-Interferon in Non-Cirrhotic Hepatitis C Patients Who Did Not Respond to Interferon or Interferon Plus Ribavirin Clinical research trials and Thymosin Plus PEG-Interferon in Non-Cirrhotic Hepatitis C Patients Who Did Not Respond to Interferon or Interferon Plus Ribavirin medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Thymosin Plus PEG-Interferon in Non-Cirrhotic Hepatitis C Patients Who Did Not Respond to Interferon or Interferon Plus Ribavirin. Thymosin Plus PEG-Interferon in Non-Cirrhotic Hepatitis C Patients Who Did Not Respond to Interferon or Interferon Plus Ribavirin Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Thymosin Plus PEG-Interferon in Non-Cirrhotic Hepatitis C Patients Who Did Not Respond to Interferon or Interferon Plus Ribavirin clinical trial. Test subjects typically obtain the finest healthcare available for their Thymosin Plus PEG-Interferon in Non-Cirrhotic Hepatitis C Patients Who Did Not Respond to Interferon or Interferon Plus Ribavirin condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > Thymosin Plus PEG-Interferon in Non-Cirrhotic Hepatitis C Patients Who Did Not Respond to Interferon or Interferon Plus Ribavirin  Thymosin Plus PEG-Interferon in Non-Cirrhotic Hepatitis C Patients Who Did Not Respond to Interferon or Interferon Plus Ribavirin
Thymosin Plus PEG-Interferon in Non-Cirrhotic Hepatitis C Patients Who Did Not Respond to Interferon or Interferon Plus Ribavirin
For Condition: Hepatitis C, Chronic,Hepatitis C
Status: No longer recruiting
Sponsor(s): SciClone Pharmaceuticals ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 500
Location and Contact Information:
Metro Health Medical Center, GI Division
Cleveland, Ohio,
United States
Ponce School of Medicine
Ponce, ,
Puerto Rico
University of Florida
Gainesville, Florida,
United States
Hepatitis C Treatment Centers, Inc.
Louisville, Kentucky,
United States
Atlanta Gastroenterology Associates
Atlanta, Georgia,
United States
Saint Louis University Hospital
St. Louis, Missouri,
United States
NY VAMC
New York City, New York,
United States
University of Tennessee Gastroenterology
Memphis, Tennessee,
United States
GI Center MidSouth
Memphis, Tennessee,
United States
Washington Hospital Center
Washington D.C., District of Columbia,
United States
Duke University Medical Center
Durham, North Carolina,
United States
Fundacion de Investigacion de Diego
Santurce, ,
Puerto Rico
University of Alabama - Knollwood Physician's Group Bldg.
Mobile, Alabama,
United States
Mayo Clinic
Scottsdale, Arizona,
United States
University of Miami Center for Liver Diseases
Miami, Florida,
United States
University of Chicago Hospital & Clinic
Chicago, Illinois,
United States
William Beaumont Hospital
Royal Oak, Michigan,
United States
University of Pennsylvania Hospital
Philadelphia, Pennsylvania,
United States
McGuire Research Institute
Richmond, Virginia,
United States
Baylor University Medical Center
Dallas, Texas,
United States
VAMC
Kansas City, Missouri,
United States
California Pacific Medical Center
San Francisco, California,
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia,
United States
Bronx VA Medical Center
New York City, New York,
United States
New England Medical Center
Boston, Massachusetts,
United States
Chevy Chase Clinical Research
Chevy Chase, Maryland,
United States
Idaho Gastroenterology Associates
Meridian, Idaho,
United States
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin,
United States
Scripps Clinic
La Jolla, California,
United States
North Shore University Hospital
Manhasset, New York,
United States
Cedars-Sinai Medical Center
Los Angeles, California,
United States
University of Texas Southwestern Medical Center
Dallas, Texas,
United States
Center for Digestive and Liver Health
Savannah, Georgia,
United States
Roger Williams Medical Center
Providence, Rhode Island,
United States
Louisiana State University Healthcare Network
New Orleans, Louisiana,
United States
Oregon Health Sciences University
Portland, Oregon,
United States
Metropolitan Research
Fairfax, Virginia,
United States
Carolinas Center for Liver Diseases
Charlotte, North Carolina,
United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts,
United States
Mississippi Gastrointestinal Associates
Jackson, Mississippi,
United States
Baylor, VAMC
Houston, Texas,
United States
Veterans Administration Medical Center GI Section (111B)
San Francisco, California,
United States
Gastroenterology Associates of East Bay Medical Group
Berkeley, California,
United States
Mayo Clinic
Jacksonville, Florida,
United States
University of Cincinnati - College of Medicine
Cincinnati, Ohio,
United States
Liver Research Center - University of Louisville
Louisville, Kentucky,
United States
Johns Hopkins University
Baltimore, Maryland,
United States
NYU Hospitals Center
New York City, New York,
United States
Additional Information:
Study ID Numbers: Ta1-CHC-2K0803a;
Study Start Date: April 2002
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00040027
Other Hepatitis C, Chronic Studies:
1. ISIS 14803-CS2, Treatment with ISIS 14803, Administered IV in Patients with Chronic Hepatitis C Virus Infections
2. Thymosin Plus PEG-Interferon in Hepatitis C Patients with Cirrhosis Who Did Not Respond to Interferon or Interferon Plus Ribavirin
3. IdB 1016 Treatment for Hepatitis C Disease
4. Thymosin Plus PEG-Interferon in Non-Cirrhotic Hepatitis C Patients Who Did Not Respond to Interferon or Interferon Plus Ribavirin
5. Addition of ISIS 14803 to therapy with peginterferon and ribavirin for chronic HCV patients not responding adequately to the two drugs.
Related Studies:
Other Hepatitis C, Chronic Clinical Trials
Other Missouri Clinical Trials
Other St. Louis Clinical Trials
Thymosin Plus PEG-Interferon in Non-Cirrhotic Hepatitis C Patients Who Did Not Respond to Interferon or Interferon Plus Ribavirin
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