EUCTR2011-002732-70-IT进行中（未招募）1 期
A phase IIIb parallel group, open label study of pegylated interferon alfa-2a monotherapy (PEG-IFN, Ro 25-8310) compared to untreated control in children with HBeAg positive chronic hepatitis B. - PEAR
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 161
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
- •Male or female subjects aged 3 to <18 years old at baseline.
- •Positive HBsAg for more than 6 months.
- •Positive HBeAg and detectable HBV DNA at screening (subjects must have
- •>10,000 copies/mL [>2,000 IU/mL] as measured by PCR).
- •Negative anti-HBs and anti-HBe at screening.
- •A liver biopsy obtained within the past 2 years prior to baseline (and more than 6 months after the end of any previous therapy for Hepatitis B) to confirm the presence of advanced fibrosis or exclude cirrhosis
- •Compensated liver disease (Child-Pugh Class A clinical classification)
- •Elevated serum ALT >ULN but = 10 × ULN as determined by two abnormal values taken =14 days apart during the six months before the first dose of study drug with at least one of the determinations obtained =35 days prior to the first dose. Reference range at local site should be used.
- •Normal thyroid gland function at screening assessed by TSH, FT3, FT4, TPO antibodies and TBG determination.
- •Signed informed consent from legal guardian and willingness of legal guardian to abide by the requirements of the study, and signed assent from child if appropriate.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 160
- •F.1.2 Adults (18-64 years) no
- •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
排除标准
- •Subjects with cirrhosis
- •Subjects who have received investigational drugs or licensed treatments with anti-HBV activity within 6 months prior to baseline (e.g. IFNs, systemic corticosteroids,
- •lamivudine, tenofovir, emtricitabine, adefovir, entecavir, telbivudine, systemic acyclovir, systemic famciclovir). (Exception: subjects who have had a limited (=7 day) course of acyclovir for herpetic lesions more than 1 month before the study
- •baseline visit are not excluded.)
- •Known hypersensitivity to PEG-IFN.
- •Positive test results at screening for HAV IgM Ab, anti-HCV Ab, anti-HDV Ab or anti-HIV Ab.
- •History or other evidence of a medical condition associated with chronic liver disease other than CHB.
- •History or other evidence of bleeding from esophageal varices.
- •Decompensated liver disease (e.g. ascites, varices, Child-Pugh Class B or C clinical
- •classification).
- •History or other evidence of metabolic liver disease.
- •Suspicion of hepatocellular carcinoma on ultrasound or other liver imaging. (All subjects to have ultrasound during screening.)
- •Screening Alfa-fetoprotein (AFP) =100 ng/mL.
- •Screening neutrophil count <1.5 x 109 cells/L, platelet count <90 x 109 cells/L, or hemoglobin <11 g/dL for females and <12 g/dL for males.
- •Screening serum creatinine concentration >1.5 x ULN for age or severe renal disease e.g. glomerulonephritis.
- •Autoimmune hepatitis.
- •History of immunologically mediated disease to include but not limited to:
- •inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus
- •erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, or clinical evidence of rheumatoid arthritis.
- •Major depression or history of psychiatric disorder, such as major psychoses, suicidal ideation, and/or suicide attempt, where clinical trial participation would be
- •inappropriate.
- •History or other evidence of chronic pulmonary or cardiac disease associated with clinically significant functional limitation.
- •History of thyroid disease poorly controlled on prescribed medications.
- •Poorly controlled diabetes.
- •History of solid organ or bone marrow transplantation.
- •Evidence of an active or suspected cancer or a history of malignancy in which the risk of recurrence was/is >20% within 2 years.
- •History of having received any systemic anti-neoplastic (including radiation) or immunomodulatory treatment (including systemic corticosteroids) =6 months prior to
- •the study baseline visit or the expectation that such treatment will be needed at any time during the study. (Exception: Topical corticosteroids, corticosteroids
- •prescribed as physiological replacement therapies, or short courses [= 7 days] of
- •systemic corticosteroids.)
- •Coagulopathy (international normalized ratio >1.5), hemoglobinopathy, hemophilia,
- •or history of severe illness or other blood disorders that would make subject
- •unsuitable for the study.
- •History of seizure disorder requiring treatment with anticonvulsant medication
- •(excluding febrile seizures).
- •History or other evidence of severe retinopathy.
- •History or other evidence of severe illness or any other conditions which would make the subject, in the opinion of the investigator, unsuitable for the study.
- •Active substance abuse within the last 6 months before the study.
- •Sexually active females of childbearing potential and sexually active males who are not willing to utilize reliable contraception during the treatment/principal observation
研究者
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