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The Response and Outcomes of Pegylated Interferon Plus Ribavirin Combination Therapy for Chronic Hepatitis C Patients Concomitant With Hepatocellular Carcinoma

Phase 4
18 Years
Open (Enrolling)
Chronic Hepatitis C, Hepatocellular Carcinoma

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Trial Information

The Response and Outcomes of Pegylated Interferon Plus Ribavirin Combination Therapy for Chronic Hepatitis C Patients Concomitant With Hepatocellular Carcinoma

A prospective, hospital-based study enrolling 100 chronic hepatitis C patients concomitant
with hepatocellular carcinoma and other sex- and age-matched 100 chronic hepatitis C
patients without malignancy will be conducted. The 100 chronic hepatitis C patients
concomitant with hepatocellular carcinoma will receive pegylated interferon-alpha 2a plus
ribavirin combination therapy at remission phase after oncological treatments and/or
interventions. The other 100 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.

Inclusion Criteria:

- Male and female patients >18 years of age

- Histopathological diagnosis of hepatocellular carcinoma >3 months before entry (Arm

- Received curative therapies, including surgery, ablation therapy or liver
transplantation >3 months before entry (ArmA)

- No evidence of hepatocellular carcinoma by imaging or histopathological studies at

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy: sustained virological response (SVR), HCV RNA seronegative by PCR throughout 24-week off-treatment period.

Outcome Time Frame:

1.5 years

Safety Issue:


Principal Investigator

Wan-Long Chuang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Kaohsiung Medical University


Taiwan: Department of Health

Study ID:




Start Date:

January 2007

Completion Date:

February 2010

Related Keywords:

  • Chronic Hepatitis C
  • Hepatocellular Carcinoma
  • chronic hepatitis C
  • sustained virological response
  • peginterferon
  • ribavirin
  • neoplasm
  • Carcinoma
  • Hepatitis
  • Hepatitis A
  • Hepatitis, Chronic
  • Hepatitis C
  • Hepatitis C, Chronic
  • Carcinoma, Hepatocellular