EUCTR2006-000421-62-FR进行中（未招募）1 期
A Comparative Study of Chronic Hepatitis B Subjects Treated with Entecavir PlusTenofovir Combination Therapy vs Entecavir Monotherapy in Adults who are Treatment-Naïve to Nucleosides and Nucleotides: The BE-LOW Study.Revised Protocol 01, incorporating protocol amendment 02 (Version 2.0, Date 22-Jan-07). - The BE-LOW Study
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
- 462
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
- •2) Nucleoside- and nucleotide-naïve subjects with chronic HBV infection (detectable
- •HBsAg at screening and for at least 24 weeks prior to screening, or detectable
- •HBsAg for < 24 weeks and negative for IgM core antibody);
- •3) Subjects must have compensated liver function and must meet ALL of the
- •following criteria:
- •International Normalization Ratio (INR) =< 1.5
- •Serum albumin >= 3 g/dL (>= 30 g/L)
- •Serum total bilirubin =< 2.5 mg/dL (=< 42.75 µmol/L)
- •4) For HBeAg-positive subjects, HBV DNA >= 172,000 IU/mL (approximately 1,000,000 copies/mL) by PCR at screening; OR For HBeAg-negative subjects, HBV DNA >=17,200 IU/mL (approximately 100,000 copies/mL) by PCR at screening;
- •5) ALT >= 1.3 x the ULN at screening and at least once >= 12 weeks prior to screening;
- •6) Males and females >= 16 years of age (or minimum age of consent in a given
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) 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;
- •2) WOCBP using a prohibited contraceptive method. At this time there are no
- •known contraindicated contraceptives to entecavir or tenofovir;
- •3) Women who are pregnant or breastfeeding;
- •4) Women with a positive pregnancy test on enrollment or prior to investigational
- •product administration;
- •5) Sexually active fertile men not using effective birth control if their partners are
- •6) Evidence of decompensated cirrhosis including but not limited to: variceal
- •bleeding; hepatic encephalopathy; or ascites requiring management with diuretics
- •or paracentesis;
- •7) Coinfection with HIV, hepatitis C virus ([HCV]; coinfection is defined as HCV
- •Ab-positive with detectable HCV ribonucleic acid [RNA] by PCR), or hepatitis D
- •virus (HDV);
- •8) Recent history of pancreatitis (within 24 weeks prior to the first dose of study
- •medication);
- •9) Currently abusing illegal drugs or alcohol sufficient, in the Investigator’s opinion,
- •to prevent adequate compliance with study therapy or to increase the risk of
- •hepatotoxicity or pancreatitis;
- •10) Other serious medical conditions that might preclude completion of this study or
- •that require chronic administration of prohibited medications (see Exclusion
- •Criterion 19);
- •11) Serum creatinine > 1.5 mg/dL;
- •12) Hemoglobin < 10.0 g/dL;
- •13) Platelet count < 70,000/mm³;
- •14) Absolute neutrophil count < 1500 cells/mm³;
- •15) Serum alpha fetoprotein (AFP) level > 100 ng/mL;
- •If the AFP level is between 21 and 100 ng/mL, it must be repeated prior to
- •randomization. If the repeat AFP level is between 21 and 100 ng/mL, and if
- •ultrasonography or computerized tomography (CT) of the liver performed
- •prior to the first dose of study medication does not demonstrate a focal lesion
- •suggestive of carcinoma, the subject may be dosed in the study;
- •16) Known history of allergy to nucleoside or nucleotide analogues;
- •17) Any prior therapy with nucleoside or nucleotide analogue antiviral agents with
- •activity against hepatitis B (e.g., adefovir, entecavir, famciclovir, tenofovir,
- •telbivudine, clevudine, emtracitabine), or any other experimental anti-HBV
- •18) Therapy with interferon; thymosin alpha or other immuno-stimulators within
- •24 weeks of randomization into this study;
- •19) Required chronic administration of medications which cause immunosuppression
- •or which are associated with a high risk of nephrotoxicity or hepatotoxicity or
- •which affect renal excretion (See Protocol Section 5.5.1 for examples);
- •20)Prisoners or subjects who are compulsorily detained (involuntarily incarcerated)
- •for treatment of either a psychiatric or physical (e.g., infectious disease) illness
- •must not be enrolled into this study;
- •21) Unable to tolerate oral medication;
- •22) Poor peripheral venous access.
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