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

This study has been completed.
Sponsor:
Information provided by:
SciClone Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00039962
First received: June 17, 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 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


Condition Intervention Phase
Hepatitis C
Hepatitis C, Chronic
Drug: thymalfasin (thymosin alpha 1)
Drug: 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: May 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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00039962

  Show 56 Study Locations
Sponsors and Collaborators
SciClone Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00039962     History of Changes
Other Study ID Numbers: Ta1-CHC-2K0804
Study First Received: June 17, 2002
Last Updated: January 8, 2008
Health Authority: United States: Food and Drug Administration

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

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
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on April 20, 2014