chronic hepatitis B, HBeAg-negative MedDRA version: 14.1 Level: PT Classification code 10019731 Term: Hepatitis B System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Pegasys
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Peginterferon alfa-2a
Concentration unit: µg microgram(s)
Concentration number: 180-
Sponsors
ROCHE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Male and female patients >18 and 6 months, anti-HBs negative, HBeAg-negative, anti-HBe positive ? ALT >ULN but 2.5x ULN but 105 copies /mL ? Liver biopsy carried out within the preceding 18 months demonstrating liver disease consistent with chronic hepatitis with Ishak Fibrosis Score >2 ? Patients with a histological diagnosis of cirrhosis (Ishak Fibrosis Score 6) and compensated liver disease (Child A, score 5) can be included. ? 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. Are the trial subjects under 18? no Number of subjects for this age range: 0 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ? Interferon-based therapy or any systemic anti-HBV 1.5x ULN and HBV DNA >100,000 copies/mL on treatment) to a previous IFN therapy will be excluded.Patients who developed clinical resistance to lamivudine (re-emergence of HBV DNA >100,000 copies/mL after an initial drop at the beginning of therapy) will be excluded.? Compensated liver disease Child A score 6 or decompensated liver disease (Child B or C) or history or other evidence of GI bleeding or endoscopic evidence of GI varices >grade 2.? Positive test at screening for anti-HAV IgM, anti-HIV, anti-HCV, anti-HDV IgG ? History or other evidence of a medical condition associated with chronic liver disease other than HBV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease including Wilson's disease and alpha1-antitrypsin deficiency, alcoholic liver disease, toxin exposures, thalassemia) ? Women with ongoing pregnancy or breast feeding ? Neutrophil count 1.5 times the upper limit of normal at screening or evidence of severe renal disease ? 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.? Evidence of drug abuse or treatment with methadone within one year of study entry ? Patients consuming alcohol in excess of 20g/day for women and 30g/day for men in the 6 months preceding enrollment ? History of a severe seizure disorder or current anticonvulsant use ? History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, psoriasis, rheumatoid arthritis etc.) ? History or other evidence of chronic pulmonary disease associated with functional limitation ? History of severe cardiac disease (e.g., NYHA Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina or other significant cardiovascular diseases) ? History of major organ transplantation with an existing functional graft ? 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 ? Evidence of an active or suspected cancer or a history of malignancy where the risk of recurrence is 20% within 2 years.Patients with a lesion suspicious for hepatic malignancy on a screening imaging study will be excluded.? Patients w
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This is an exploratory immunological investigation which has the objective to understand the extent and nature of the antigen-specific and non-specific immune defects in patients with HBeAg-negative CHB and their modulation by therapy with PEGASYS during the first 6 months of treatment;Secondary Objective: -;Primary end point(s): This is an exploratory immunological study. | — |
Countries
Italy
Outcome results
None listed