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Thymosin Plus PEG-Interferon in Hepatitis C Patients with Cirrhosis Who Did Not Respond to Interferon or Interferon Plus Ribavirin Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Thymosin Plus PEG-Interferon in Hepatitis C Patients with Cirrhosis Who Did Not Respond to Interferon or Interferon Plus Ribavirin conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Thymosin Plus PEG-Interferon in Hepatitis C Patients with Cirrhosis Who Did Not Respond to Interferon or Interferon Plus Ribavirin Clinical research trials and Thymosin Plus PEG-Interferon in Hepatitis C Patients with Cirrhosis Who Did Not Respond to Interferon or Interferon Plus Ribavirin health trials occur in hundreds of cities 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 typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Thymosin Plus PEG-Interferon in Hepatitis C Patients with Cirrhosis Who Did Not Respond to Interferon or Interferon Plus Ribavirin. Thymosin Plus PEG-Interferon in Hepatitis C Patients with Cirrhosis Who Did Not Respond to Interferon or Interferon Plus Ribavirin Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Thymosin Plus PEG-Interferon in Hepatitis C Patients with Cirrhosis Who Did Not Respond to Interferon or Interferon Plus Ribavirin clinical trial. Participants oftentimes recieve the most expert healthcare available for their Thymosin Plus PEG-Interferon in Hepatitis C Patients with Cirrhosis Who Did Not Respond to Interferon or Interferon Plus Ribavirin condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > Thymosin Plus PEG-Interferon in Hepatitis C Patients with Cirrhosis Who Did Not Respond to Interferon or Interferon Plus Ribavirin  Thymosin Plus PEG-Interferon in Hepatitis C Patients with Cirrhosis Who Did Not Respond to Interferon or Interferon Plus Ribavirin
Thymosin Plus PEG-Interferon in Hepatitis C Patients with Cirrhosis Who Did Not Respond to Interferon or Interferon Plus Ribavirin
For Condition: Hepatitis C,Hepatitis C, Chronic
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 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
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 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: - Use of systemic corticosteroids within 6 months of entry. - 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.
Total Enrollment: 500
Location and Contact Information:
Duke University Medical Center
Durham, North Carolina,
United States
LSU Healthcare Network
New Orleans, Louisiana,
United States
University of Cincinnati College of Medicine
Cincinnati, Ohio,
United States
North Shore University Hospital
Manhasset, New York,
United States
Albert Einstein Medical Center
Philadelphia, Pennsylvania,
United States
Mayo Clinic
Jacksonville, Florida,
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia,
United States
Austin Gastroenterology PA
Austin, Texas,
United States
Fundacion de Investigacion de Diego
Santurce, ,
Puerto Rico
Medical University of South Carolina
Charleston, South Carolina,
United States
Huntington Memorial Hospital
Pasadena, California,
United States
California Pacific Medical Center
San Francisco, California,
United States
University of California, Davis Medical Center
Sacramento, California,
United States
Oregon Health Sciences University
Portland, Oregon,
United States
Kaiser Permanente
Sacramento, California,
United States
University of Louisville
Louisville, Kentucky,
United States
Baylor University Medical Ctr.
Dallas, Texas,
United States
Advanced Clinical Research
Providence, Rhode Island,
United States
Scripps Clinic
La Jolla, California,
United States
Arapahoe Gastroenterology
Littleton, Colorado,
United States
Baylor College of Medicine
Houston, Texas,
United States
University of Chicago Hospital & Clinic
Chicago, Illinois,
United States
Washington Hospital Center
Washington D.C., District of Columbia,
United States
Mississippi Gastrointestinal Associates
Jackson, Mississippi,
United States
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin,
United States
VAMC
Kansas City, Missouri,
United States
San Mateo Medical Center
San Mateo, California,
United States
Metropolitan Research
Fairfax, Virginia,
United States
University of Pennsylvania
Philadelphia, Pennsylvania,
United States
Carolinas Center for Liver Disease
Charlotte, North Carolina,
United States
University Of Miami Center for Liver Diseases
Miami, Florida,
United States
Advanced Clinical Research Institute
Anaheim, California,
United States
Metro Health Medical Ctr.
Cleveland, Ohio,
United States
NYU Gastroenterology & Hepatology
New York City, New York,
United States
Johns Hopkins University
Baltimore, Maryland,
United States
Digestive Healthcare of Georgia
Atlanta, Georgia,
United States
Gastroenterology Associates of East Bay Medical Group
Berkeley, California,
United States
The Cleveland Clinic Foundation
Cleveland, Ohio,
United States
Jefferson University Physicians
Philadelphia, Pennsylvania,
United States
Loma Linda University Medical Center
Loma Linda, California,
United States
McGuire DVAMC
Richmond, Virginia,
United States
William Beaumont Hospital
Royal Oak, Michigan,
United States
Chevy Chase Clinical Research
Chevy Chase, Maryland,
United States
Idaho Gastroenterology Associates
Meridian, Idaho,
United States
University of Tennessee Gastroenterology
Memphis, Tennessee,
United States
Baylor, VAMC
Houston, Texas,
United States
Mayo Clinic
Scottsdale, Arizona,
United States
University of Alabama - Knollwood Physician's Group
Mobile, Alabama,
United States
Ponce School of Medicine
Ponce, ,
Puerto Rico
University of Florida
Gainesville, Florida,
United States
Bradley Freilich MD, LLC
Kansas City, Missouri,
United States
VA Harbor HealthCare System
New York City, New York,
United States
Center for Digestive and Liver Health
Savannah, Georgia,
United States
Kaiser Permanente
Santa Clara, California,
United States
Endoscopic Microsurgery Associates
Towson, Maryland,
United States
New England Medical Center
Boston, Massachusetts,
United States
Additional Information:
Study ID Numbers: Ta1-CHC-2K0804;
Study Start Date: May 2002
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00039962
Other Hepatitis C Studies:
1. Thymosin Plus PEG-Interferon in Non-Cirrhotic Hepatitis C Patients Who Did Not Respond to Interferon or Interferon Plus Ribavirin
2. Evaluating Silymarin for Chronic Hepatitis C
3. Addition of ISIS 14803 to therapy with peginterferon and ribavirin for chronic HCV patients not responding adequately to the two drugs.
4. IdB 1016 Treatment for Hepatitis C Disease
5. Thymosin Plus PEG-Interferon in Hepatitis C Patients with Cirrhosis Who Did Not Respond to Interferon or Interferon Plus Ribavirin
Related Studies:
Other Hepatitis C Clinical Trials
Other New York Clinical Trials
Other Manhasset Clinical Trials
Thymosin Plus PEG-Interferon in Hepatitis C Patients with Cirrhosis Who Did Not Respond to Interferon or Interferon Plus Ribavirin
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