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

Sponsoren

Hauptsponsor: SciClone Pharmaceuticals

Quelle SciClone Pharmaceuticals
Kurze Zusammenfassung

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.

Gesamtstatus Completed
Anfangsdatum April 2002
Phase Phase 3
Studientyp Interventional
Einschreibung 500
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: thymalfasin (thymosin alpha 1) + PEGinterferon alfa-2a

Interventionsart: Drug

Interventionsname: placebo + PEGinterferon alfa-2a

Teilnahmeberechtigung

Kriterien:

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.

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: N/A

Gesunde Freiwillige: No

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

Puerto Rico

United States

Überprüfungsdatum

January 2008

Schlüsselwörter
Bedingung Durchsuchen
Studiendesign Info

Zuweisung: Randomized

Interventionsmodell: Parallel Assignment

Hauptzweck: Treatment

Maskierung: Double

Quelle: ClinicalTrials.gov