EUCTR2009-016357-17-GR进行中（未招募）1 期
A Comparative Study of the Antiviral Efficacy and Safety of Entecavir (ETV) versus Placebo in Pediatric Subjects with Chronic Hepatitis B Virus (HBV) Infection who are HBeAg-Positive
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
- 257
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
- •1) Signed Written Informed Consent
- •a) Freely given informed consent must be obtained prior to clinical trial
- •participation, including informed consent for any screening procedures conducted
- •to establish subject eligibility for the trial. Minor’s parents or legally acceptable
- •representatives must give fully informed written consent. Assent should be
- •obtained when the minor is judged to be of an age of reason (see Appendix 1);
- •2) Target Population
- •a) History of CHB infection defined as HBsAg-positive at the Screening visit and on
- •at least one other occasion = 24 weeks prior to screening;
- •b) Detectable HBeAg AND no detectable anti-HBe antibodies at screening and at
- •least once = 4 weeks prior to screening;
- •c) Serum ALT 1.5 to < 10 x ULN at screening and at least on one other occasion
- •within 8 to 24 weeks prior to screening;
- •d) HBV DNA by PCR = 100 000 copies/mL at screening and evidence of the presence of
- •HBV DNA at least once = 4 weeks prior to screening;
- •3) Age and Sex
- •a) Male and females, 2 to <18 years of age.
- •Women of childbearing potential (WOCBP) must be using an adequate method of
- •contraception to avoid pregnancy throughout the study and for up to 6 weeks after
- •the last dose of investigational product in such a manner that the risk of pregnancy
- •is minimized.
- •WOCBP include any female who has experienced menarche and who has not
- •undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation,
- •or bilateral oophorectomy) or is not postmenopausal. Post menopause is defined
- •Amenorrhea = 12 consecutive months without another cause or
- •For women with irregular menstrual periods and on hormone replacement
- •therapy (HRT), a documented serum follicle stimulating hormone (FSH) level
- •> 35 mIU/mL
- •Women who are using oral contraceptives, other hormonal contraceptives
- •(vaginal products, skin patches, or implanted or injectable products), or
- •mechanical products such as an intrauterine device or barrier methods
- •(diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing
- •abstinence or where their partner is sterile (eg, vasectomy) should be considered
- •to be of childbearing potential.
- •WOCBP must have a negative serum or urine pregnancy test (minimum
- •sensitivity 25 IU/L or equivalent units of HCG) at screening AND within
- •72 hours prior to the start of investigational product.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •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
- •1) Sex and Reproductive Status
- •a) WOCBP who are unwilling or unable to use an acceptable method to avoid
- •pregnancy for the entire study period and for up to 6 weeks after the last dose of
- •investigational product;
- •b) WOCBP using a prohibited contraceptive method. At this time there are no
- •known contraindicated contraceptives to entecavir;
- •c) Women who are pregnant or breastfeeding;
- •d) Women with a positive pregnancy test on enrollment or prior to investigational
- •product administration;
- •e) Sexually active fertile men not using effective birth control if their partners are
- •2) Target Disease Exceptions
- •a) Co-infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV)
- •or hepatitis D virus (HDV);
- •b) Other forms of acute and chronic conditions which may cause increased ALT as
- •determined by the investigators (eg, acute viral illness, Wilson Disease, other
- •metabolic disorders, autoimmune hepatitis, alcoholic liver disease);
- •c) Liver transplant recipients;
- •3) Medical History and Concurrent Diseases
- •a) Current evidence of, or history of variceal bleeding, hepatic encephalopathy, or
- •ascites requiring diuretics or paracentesis or evidence of these on physical
- •examination performed for this study;
- •b) Current evidence of, or history of pancreatitis;
- •c) Received bone marrow or organ transplant or therapy with an
- •immunomodulatory, cytotoxic, or systemic corticosteroid therapies within
- •2 months of enrollment;
- •d) Evidence of current pre-malignant lesions and malignancies including HCC; (to
- •be excluded by screening and evaluation practices standard in the country of
- •enrollment);
- •e) Other serious medical conditions that might preclude completion of this study;
- •4) Physical and Laboratory Test Findings
- •a) Hemoglobin < 10.0 g/dL;
- •b) Platelet count < 70,000/mm³
- •c) Inadequate renal function with estimated glomerular filtration rate of
- •< 50 mL/min/1.73m² (using the Schwartz formula; [k * Ht]/Cr)
- •d) Total serum bilirubin > 2.5 mg/dL (> 42.75 µmol/L);
- •e) INR > 1.5;
- •f) Serum albumin < 3.0 g/dL (< 30 g/L);
- •g) Alpha Fetoprotein = 50 ng/mL;
- •Allergies and Adverse Drug Reactions
- •a) Known allergy to nucleoside analogues;
- •Prohibited Treatments and/or Therapies
- •a) = 12 weeks of prior therapy with any nucleoside or nucleotide antiviral agent with
- •activity against hepatitis B virus (including but not limited to adefovir, tenofovir,
- •famciclovir, clevudine, lamivudine, telbivudine, or emtricitabine);
- •b) Therapy with interferon alpha, thymosin alpha or any nucleos[t]ide antiviral agent
- •with activity against hepatitis B virus within 24 weeks of screening;
- •c) Any prior therapy with ETV;
- •d) Any use of illegal drugs OR use of alcoholic beverages which in the investigator’s
- •opinion is sufficient to prevent adequate compliance with study procedures or
- •increase the risk pancreatitis or hepatotoxicty;
- 另有 11 项未显示
研究者
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