Peginterferon Plus Ribavirin for Hepatitis C Patients Concomitant With Malignancy Other Than Hepatocellular Carcinoma

Kaohsiung Medical University

Status and phase

Completed

Phase 4

Conditions

Neoplasms

Chronic Hepatitis C

Treatments

Drug: pegylated interferon alpha 2a and plus ribavirin

Study type

Interventional

Funder types

Other

Identifiers

NCT00630084

KMUH-IRB-960044

Details and patient eligibility

About

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 safety of pegylated interferon-alpha plus ribavirin combination therapy and its impact on the outcome in chronic hepatitis C patients concomitant with malignancy other than hepatocellular carcinoma deserve to be elucidated.

The purposes of this study are:

To evaluate the efficacy and safety of pegylated interferon-alpha 2a plus ribavirin combination therapy in chronic hepatitis C patients concomitant with malignancy other than hepatocellular carcinoma, compare to those without systemic malignancy.
To investigate the role of baseline and on-treatment factors on the response to pegylated interferon-alpha 2a plus ribavirin combination therapy in chronic hepatitis C patients concomitant with malignancy other than hepatocellular carcinoma.

Full 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 patients without malignancy will be conducted. The 40 chronic hepatitis C patients concomitant with malignancy other than hepatocellular carcinoma will receive pegylated interferon-alpha 2a plus ribavirin combination therapy at remission phase after oncological treatments and/or interventions. The other 80 chronic hepatitis C patients without malignancy receiving the same antiviral therapy will serve as controls. The primary outcome measurement is sustained virological response and safety, whilst the secondary measurement is rapid virological and early virological response.

Enrollment

120 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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