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

This study has been completed.
Sponsor:
Information provided by:
SciClone Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00040027
First received: June 18, 2002
Last updated: January 8, 2008
Last verified: January 2008
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by SciClone Pharmaceuticals:

Estimated Enrollment: 500
Study Start Date: April 2002
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00040027

  Show 48 Study Locations
Sponsors and Collaborators
SciClone Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00040027     History of Changes
Other Study ID Numbers: Ta1-CHC-2K0803a
Study First Received: June 18, 2002
Last Updated: January 8, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by SciClone Pharmaceuticals:
hepatitis C
hepatitis C, chronic

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Thymalfasin
Interferon-alpha
Peginterferon alfa-2a
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on September 11, 2014