Overview

Peginterferon Plus Ribavirin Combination Therapy for Hepatitis C Six Months After Onset of Acute Infection

Status:
Completed
Trial end date:
2016-02-01
Target enrollment:
0
Participant gender:
All
Summary
Patients with acute hepatitis C virus (HCV) infection usually become chronicity if viremia persists after 6 months of infection. The result of using pegylated interferon plus ribavirin combination therapy upon these patients remains to be explored
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Treatments:
Interferon alpha-2
Interferon-alpha
Interferons
Peginterferon alfa-2a
Ribavirin
Criteria
Inclusion Criteria:

- Male and female patients 18-80 years of age

- 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 for > 6 months

- Compensated liver disease

- 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 or history 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

- Local or Systemic malignancy unstable status