NL-OMON32978已完成不适用
A randomized open-label prospective trial for comparing combination therapy Peg-Interferon alfa-2a (PEGASYS®) and Adefovir dipivoxil (Hepsera®) and combination therapy Peg-Interferon alfa-2a (PEGASYS®) and Tenofovir disoproxil fumarate (Viread®) versus no treatment in HBeAg negative chronic hepatitis B patients with low viral load* - HBsAg loss during treatment with Peg-IFN combined with ADV or TDF
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1.Male and female patients > 18 and <= 70 years of age
- •2.Positive HBsAg for more than 6 months.
- •3.Negative for HBeAg for more than 6 months.
- •4.Patients with chronic hepatitis B who are either naive to antiviral treatment, or have received either interferon (IFN) or nucleoside/nucleotide analogues in the past but are still positive for HBsAg.
- •5.Serum ALT< 5 * ULN as determined by two values taken >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
排除标准
- •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) <3 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study.
- •4.Positive test at screening for anti-HAV IgM, anti-HIV, HCV RNA. (Patients that have cleared the hepatitis C virus can be included in the study)
- •5.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 (<7 day) course of acyclovir for herpetic lesions more than 1 month prior to the first administration of test drug are not excluded.
- •6.Evidence of decompensated liver disease (Child Pugh B-C)
- •7.Serum total bilirubin > 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 <1500 cells/mm3 or platelet count <80,000 cells/mm3 at screening.
- •12.Hemoglobin < 7.1 mmol/L (< 11.5 g/dL) for females and < 7.8 mmol/L (< 12.5 g/dL) for men at screening.
- •13.Serum creatinine level >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).
研究者
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