Chronic hepatitis B MedDRA version: 9.1 Level: LLT Classification code 10008910 Term: Chronic hepatitis B
Conditions
Interventions
Trade Name: Pegasys 180 micrograms solution for injection
Pharmaceutical Form: Solution for injection
INN or Proposed INN: peginterferon-alfa 2a
Current Sponsor code: RO 25-8310
Concentration unit: µg
Sponsors
F.Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Age >= 18 years •Positive HBsAg for more than 6 months, positive HBeAg, detectable HBV DNA (patients must have > 500,000 copies/ml (100,000 IU/ml) as measured by PCR) and anti HBs negative •Elevated serum ALT > ULN but = 14 days apart during the six months before the first dose of study drug with at least one of the determinations obtained =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Patients must not have received antiviral therapy for their chronic hepatitis B within the previous 6 months. Patients who are expected to need systemic antiviral therapy other than that provided by the study at any time during their participation in the study are also excluded. Exception: patients who have had a limited ( 1.5 times the upper limit of normal at screening. •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 major depression or psychosis, 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). •History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease. •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 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 >= 20% within 2 years. Patients with a lesion suspicious for hepatic malignancy on a screening imaging study will only be eligible if the likelihood of carcinoma is 100 ng/mL are excluded, unless sta
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy and safety of PEG-IFN given for both varied duration, either 24 or 48 weeks and at different doses, 90 or 180mcg weekly doses in the treatment of HBeAg positive patients with chronic hepatitis B virus infection, 24 weeks after the end of therapy;Secondary Objective: To compare the influence of varied duration and dose on the secondary endpoints and in the event of equivocal findings to explore potential subsets of patients who might benefit from particular treatment regimens.;Primary end point(s): HBeAg seroconversion (loss of HBeAg and presence of anti-HBe) at the end of the initial 24 week treatment free follow up. | — |
Countries
France, Germany
Outcome results
None listed