chronic hepatitis B viral hepatitis
Conditions
Interventions
(see study design)
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1.Male and female patients > 18 and 14 days apart during the six months before the first dose of study drug with at least one of the determinations obtained during the screening period. 6.Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of test drug
Exclusion criteria
Exclusion criteria: 1.Patients co-infected with HCV, HIV or who have decompensated liver disease, hepato-cellular carcinoma, significant cardiac disease, significant renal disease, seizure disorders or severe retinopathy. 2.Patients who have received nucleos(t)ide analogues for their chronic hepatitis B within 6 weeks before enrollment or Peg-IFN within 3 months before enrollment. 3.Patients must not have received any other systemic anti-viral, anti-neoplastic or immuno-modulatory treatment (including supraphysiologic doses of steroids or radiation) twice the upper limit of normal at screening 8.History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease. 9.History or other evidence of a medical condition associated with chronic liver disease other than HBV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver diseases including Wilson*s disease and alfa1-antitrypsin deficiency, alcoholic liver disease, toxin exposures, thalassemia). 10.Women with ongoing pregnancy or who are breast feeding. 11.Neutrophil count 1.5 times the upper limit of normal at screening. 14.Unstabel ongoing severe psychiatric disease, especially depression. 15.History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis). 16.History or other evidence of chronic pulmonary and cardiac disease associated with functional limitation. 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to demonstrate the efficacy of combination therapy (Peg-IFN and adefovir or Peg-IFN and tenofovir) for inducing loss of HBsAg compared to no-treatment in HBeAg negative chronic hepatitis B patients with low viral load. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives are to evaluate: a. the rate of HBsAg loss and anti-HBs serconversion, b. To establish predictive markers at baseline and during the first 12 weeks of treatment for response of primary and secundary endpoints. | — |
Countries
Netherlands
Outcome results
None listed