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| 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 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Contacts and Locations
Hide Study 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 | |
More Information
| 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 |
|
hepatitis C hepatitis C, chronic |
|
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 |