EUCTR2012-000080-25-IT进行中（未招募）不适用
A Phase IIb, Open Label, Single Arm, Multicenter Study to Evaluate the Effect of 48-weeks Peginterferon alfa-2a (PEG-IFN) Administration on Serum HBsAg in Chronic Hepatitis B, HBeAg-Negative, Genotype D Patients on Treatment with Nucleos(t)ide Analogues (NAs), Showing Stable HBV DNA Suppression. - HERMES
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- ROCHE
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Adults (aged 18-65) with chronic hepatitis B.
- •Negative for HBeAg.
- •Infected with HBV genotype D.
- •In monotherapy with any NA but telbivudine at enrolment, and HBV DNA persistently below 20 IU/ml for at least 12 months.
- •HBsAg >100 IU/ml at the beginning of the Lead-In phase, confirmed before addition of PEG-IFN.
- •Showing a steady HBsAg kinetic (HBsAg decrease <0.5 log10 IU/ml from week -12 to start of the Add-On phase.
- •Negative pregnancy test (for women of childbearing potential) documented at baseline (prior to the first dose of PEG-IFN). Additionally, all fertile males with partners of childbearing age and females must be using reliable contraception during and for 3 months after the Add-On phase
- •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 81
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Co-infection with HAV, HCV, HDV, HIV.
- •Evidence of decompensated liver disease (Child-Pugh =6).
- •History or other evidence of a medical condition associated with chronic liver disease (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposures).
- •Known hypersensitivity to PEG-IFN.
- •Women with ongoing pregnancy or who are breast feeding.
- •Neutrophil count <1500 cells/mmc, platelet count <100,000 cells/mmc or hemoglobin <11 g/dL for females and <12 g/dL for males.
- •Evidence of alcohol and/or drug abuse within one year of study 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).
- •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 (other than basocellular carcinoma or in-situ cervical carcinoma) within a period of 5 years prior to study entry. Patients with a lesion suspicious of hepatic malignancy will be excluded.
- •History of having received any systemic anti-neoplastic (including radiation) or immunomodulatory treatment (including systemic corticosteroids) = 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 (other than corneal or hair transplantation).
- •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.
- •Serum alfa-fetoprotein > 50 mg/ml.
研究者
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