Hepatic cirrhosis due to Chronic Hepatitis C virus (HCV) infection
Conditions
Interventions
Trade Name: peginterferon alfa 2a
Product Name: Peg interferon alfa-2a
Product Code: RO 25-8310
Pharmaceutical Form: Powder and solvent for suspension for injection
Sponsors
Southampton University Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · Age > 18 years.· Serologic evidence of hepatitis C infection by an anti-HCV antibody test.· Qualitative evidence of infection with HCV RNA · Chronic liver disease consistent with chronic hepatitis C infection on a biopsy obtained prior to starting therapy as judged by a local pathologist.· Patients must have had an abdominal ultrasound, CT scan, or MRI scan without evidence of hepatocellular carcinoma (within 2 months of randomization) and a serum AFP that has not increased by 10 fold over the preceding 3 months · Negative urine pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of test drug. Additionally, all fertile male patients, male patients with female partners of childbearing age, and females must be using two reliable forms of effective contraception during the study. · Child-Pugh Grade A or B clinical classification liver disease Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: · Patients with any of the following will not be eligible for participation:· Patients who are expected to need non-HCV systemic antiviral therapy at any time during their participation in the study are also excluded. Positive test at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, or anti-HIV Ab.· Documented serum concentrations of ceruloplasmin or a1-antitrypsin consistent with an increased risk of metabolic liver disease.· History or other evidence of a medical condition associated with ongoing chronic liver disease (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposures).· Women with ongoing pregnancy or breast feeding.· Decompensated liver disease within the last three months· Neutrophil count <1500 cells/mm3, Hgb <12 g/dL in women or 13 g/dL in men, or platelet count <60,000 cells/mm3. · Evidence of alcohol and/or drug abuse within one year of entry. · 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 immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis requiring more than intermittent nonsteroidal anti-inflammatory medications for management etc.).· History or other evidence of chronic pulmonary disease associated with functional limitation.· History of a severe seizure disorder or current anticonvulsant use.· Evidence of an active or suspected cancer or a history of malignancy where the risk of recurrence is ³20% within 2 years. Patients with a lesion suspicious for hepatic malignancy on the screening imaging study will only be eligible if the likelihood of carcinoma is £10% following an appropriate evaluation.· History of having received any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) £6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study.· History of major organ transplantation with an existing functional graft.· History of thyroid disease poorly controlled on prescribed medications. Patients with elevated thyroid stimulating hormone concentrations with elevation of antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease are excluded.· History or other evidence of severe retinopathy.· Inability or unwillingness to provide informed consent or abide by the requirements of the study.· History 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy and safety of peginterferon alfa-2a (PEG-IFN) given for 48 weeks to conventional care in patients with Child's A or B cirrhosis due to chronic hepatitis C (CHC) virus infection.;Secondary Objective: To determine the effect of treatment with peginterferon alfa-2a (PEG-IFN) on qulaity of life in patients with Child's A or B cirrhosis due to chronic hepatitis C (CHC) virus infection.;Primary end point(s): Combined endpoint of non-detectable serum HCV-RNA (<100 copies/ml by the AMPLICR PCR assay) at the end of the 24 week treatment-free follow-up period. Death. Liver transplantation (or need for). Hepatocellular cancer. | — |
Countries
United Kingdom
Outcome results
None listed