EUCTR2007-001269-14-DE进行中（未招募）不适用
A Comparative Study of the Antiviral Efficacy and Safety of Entecavir Plus Tenofovirversus Adefovir Added to Continuing Lamivudine in Adults with Lamivudine ResistantChronic Hepatitis B Virus Infection. Revised Protocol 02, incorporating protocol amendment 01 (v1.0, Date 03-Jan-2008), protocol amendment 02 (v1.0, Date 31-Jul-2008) and Administrative Letter 01 (Date 06-Jun-2008).
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
- 105
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 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); subjects may be either HBeAg-positive or HBeAg-negative;
- •3) Subjects must have a history of previous lamivudine treatment, must have LVD
- •resistance substitutions at reverse transcriptase rtM204I/V ± rtL180M, documented
- •by INNO-Lipa HBV-DR assay, and must be receiving lamivudine at the screening
- •4) Subjects must have compensated liver function and must meet ALL of the following
- •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 = 172,000 IU/mL HBV DNA (approximately 106 copies/mL) by PCR at
- •6) ALT =10 x the ULN at screening;
- •7) Men and women, = 18 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) Evidence of decompensated cirrhosis including but not limited to: variceal bleeding;
- •hepatic encephalopathy; or ascites requiring management with diuretics or
- •paracentesis;
- •3) 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).
- •4) Recent history of pancreatitis (within 24 weeks prior to the first dose of study
- •medication);
- •5) 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;
- •6) Other serious medical conditions that might preclude completion of this study or that require chronic administration of prohibited medications (see Exclusion
- •Criteria 13 - 15).
- •7) Renal impairment that precludes subject from tolerating the per protocol study drug dose levels (see Protocol section 5.3.1).
- •8) Serum creatinine > 1.5 mg/dL;
- •9) Hemoglobin < 10.0 g/dL;
- •10) Platelet count < 70,000/mm3;
- •11) Absolute neutrophil count < 1500 cells/mm3;
- •12) Serum alpha fetoprotein (AFP) level > 100 ng/mL.
- •13) Known history of allergy to nucleoside or nucleotide analogues.
- •14) Except lamivudine, any prior therapy with nucleoside or nucleotide analogue antiviral agents with activity against hepatitis B (e.g., adefovir, entecavir, famciclovir,
- •tenofovir/emtricitabine, clevudine);
- •15) Therapy with interferon, thymosin alpha or other immuno-stimulators within
- •24 weeks of randomization into this study;
- •16) 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.).
- •17) Prisoners or subjects who are involuntarily incarcerated;
- •18) Subject who are compulsorily detained for treatment of either a psychiatric or
- •physical (e.g., infectious disease);
- •19) Unable to tolerate oral medication;
- •20) Poor peripheral venous access;
- •21) Off lamivudine therapy for greater than 7 days between the time of the screening visit and initiation of study treatment.
- •Subjects may be re-screened 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 consultation with the study team.
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