EUCTR2006-000421-62-IT进行中（未招募）不适用
A Comparative Study of Chronic Hepatitis B Subjects Treated with Entecavir Plus Tenofovir Combination Therapy vs Entecavir Monotherapy in Adults who are Treatment-Naïve to Nucleosides and Nucleotides: The BE-LOW Study - The BE-LOW Study
适应症
相关药物
试验速览
- 阶段
- 不适用
- 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 country)
- •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 WOCBP; 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 antiviral; 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
研究者
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