EUCTR2006-000422-31-GR进行中（未招募）不适用
A Comparative Study of Entecavir vs Adefovir Plus Lamivudine vs CombinationEntecavir plus Adefovir in Lamivudine-Resistant Chronic Hepatitis B Subjects: TheDEFINE StudyRevised Protocol 02, incorporating protocol amendment 02 (Version 2.0, date 23-Jan-2007), protocol amendment 03 (Version 4.0, date 07-Nov-2007) and Administrative Letter 01. - The DEFINE Study
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) Subjects must have a history of previous lamivudine treatment at screening, and must have LVD resistance substitutions at reverse transcriptase rtM204I/V;
- •3) Subjects must be nucleoside- and nucleotide-naïve, except for lamivudine, and
- •have chronic HBV infection (detectable HBsAg at screening and at least 24 weeks
- •prior to screening, or detectable HBsAg for < 24 weeks and negative for IgM core
- •4) 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)
- •5) HBV DNA = 17,200 IU/mL (approximately 1,00,000 copies/mL) by PCR at
- •6) ALT = 10 x ULN at screening;
- •7) Documentation of HBeAg-positive and HBeAb-negative status at screening and at
- •least once = 4 weeks prior to screening;
- •8) Males and females = 16 years of age (or minimum age of consent in a given
- •Are the trial subjects under 18? yes
- •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 does of
- •investigational product;
- •2) WOCBP using a prohibited contraceptive method. At this time there are no
- •known contraindicated contraceptives to entecavir or adefovir or lamivudine;
- •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;
- •16) Known history of allergy to nucleoside or nucleotide analogues;
- •17) Except lamivudine, 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.
- •Subjects may be rescreened twice (for a total of three screens) if it can be reasonably expected that study criteria will be met. However, beyond this, subjects should be reevaluated only after consult with the clinical team.
研究者
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