Status:
COMPLETED
Peginterferon Plus Ribavirin for Hepatitis C Patients Concomitant With Malignancy Other Than Hepatocellular Carcinoma
Lead Sponsor:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Conditions:
Chronic Hepatitis C
Neoplasms
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
Combination therapy with pegylated interferon-alpha plus ribavirin has greatly improved the treatment efficacy and is the mainstream of treatment for chronic hepatitis C infection. The efficacy and sa...
Detailed Description
A prospective, hospital-based study enrolling 40 chronic hepatitis C patients concomitant with malignancy other than hepatocellular carcinoma and other sex- and age-matched 80 chronic hepatitis C pati...
Eligibility Criteria
Inclusion
- Male and female patients \>18 years of age
- Local or Systemic malignancy other than hepatocellular carcinoma in remission or stable status
- Patients have never been treated with traditional interferon plus ribavirin or peginterferon plus ribavirin
- Serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test
- Detectable serum HCV-RNA
- Liver biopsy findings consistent with the diagnosis of chronic hepatitis C infection with or without compensated cirrhosis (Exception: hemophiliacs in whom biopsy is medically contra-indicated do not require biopsy.)
- Compensated liver disease (Child-Pugh Grade A clinical classification)
- Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug
- All fertile males and females receiving ribavirin must be using two forms of effective contraception during treatment and during the 6 months after treatment end
Exclusion
- Women with ongoing pregnancy or breast feeding
- Present therapy with any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) within 6 months prior to the first dose of study drug
- Any investigational drug 6 weeks prior to the first dose of study drug
- Co-infection with active hepatitis A, hepatitis B and/or human immunodeficiency virus (HIV)
- History or other evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
- Clinical evidence of hepatocellular carcinoma
- History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
- Neutrophil count \<1500 cells/mm3 or platelet count \<90,000 cells/mm3 at screening
- Serum creatinine level \>1.5 times the upper limit of normal at screening
- History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time or any history of the following: a suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease
- History of a severe seizure disorder or current anticonvulsant use
- History of immunologically mediated disease, chronic pulmonary disease associated with functional limitation, severe cardiac disease, major organ transplantation or other evidence of severe illness, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
- History of thyroid disease poorly controlled on prescribed medications, elevated thyroid stimulating hormone (TSH) concentrations with elevation of antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease
- Evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration)
- Evidence of drug abuse (including excessive alcohol consumption\>40 g/day) within one year of study entry
- Inability or unwillingness to provide informed consent or abide by the requirements of the study
- Male partners of women who are pregnant
- Hgb \<11 g/dL in women or \<12 g/dL in men at screening
- Any patient with major thalassemia
- Patients with documented or presumed coronary artery disease or cerebrovascular disease should not be enrolled if, in the judgment of the investigator, an acute decrease in hemoglobin by up to 4 g/dL (as may be seen with ribavirin therapy) would not be well-tolerated
- Evidence or history of hepatocellular carcinoma
- Local or Systemic malignancy unstable status
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00630084
Start Date
August 1 2006
End Date
October 1 2008
Last Update
September 4 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Kaohsiung Medical University Hospital
Kaohsiung City, Taiwan, 807