NCT00371150已完成4 期
A Study to Describe the Antiviral Effect of Entecavir (ETV) in Blacks/African Americans and Hispanics With Chronic Hepatitis B Virus (HBV) Infection Who Are Nucleoside-Naive
Bristol-Myers Squibb15 个研究点 分布在 2 个国家目标入组 131 人开始时间: 2006年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 131
- 试验地点
- 15
- 主要终点
- Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) < 50 IU/mL by Polymerase Chain Reaction (PCR) at Week 48
研究概览
简要总结
The purpose of this clinical research study is to develop observational clinical experience with the use of entecavir in participants who are either of Black/African-American race or of Hispanic ethnicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic HBV infection, with either HBeAg-positive (HBeAb-negative) or HBeAg-negative (HBeAb-positive) disease
- •Black/African American Race and/or Hispanic ethnicity
- •Nucleoside/tide-naive
- •Males or females ≥ 16 years of age (or minimum age required in a given country)
- •Compensated liver function
- •ALT of 1.3 to 10 x upper limit of normal (ULN)
- •No Co-infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis D virus (HDV)
- •Exclusion Criteria
- •Women of childbearing potential (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 study medication has been discontinued
- •Women who are pregnant or breastfeeding
- •Women with a positive pregnancy test on enrollment or prior to study drug administration
- •Evidence of decompensated cirrhosis including but not limited to: variceal bleeding; hepatic encephalopathy; or ascites requiring management with diuretics or paracentesis
- •Recent history of pancreatitis (resolution of any recent pancreatitis must be documented by normal lipase at least 12 weeks prior to the first dose of study medication)
- •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
- •Other serious medical conditions that might preclude completion of this study or that require chronic administration of prohibited medications
- •Serum creatinine > 1.5 mg/dL
- •Hemoglobin < 10.0 g/dL
- •Platelet count < 70,000/mm3
- •Absolute neutrophil count < 1200 cells/mm3
- •Serum alpha fetoprotein (AFP) level > 100 ng/mL. If the AFP level is between 21 and 100 ng/mL, it must be repeated. 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
- •Known history of allergy to nucleoside analogues
- •Any prior therapy with Entecavir
- •Any prior or concomitant use of nucleoside or nucleotide analogue antiviral agents with activity against hepatitis B (e.g., ETV, lamivudine (LVD), tenofovir [TDF], emtricitabine (FTC), clevudine, telbivudine [LdT], famciclovir), or any other experimental anti-HBV antiviral agent
- •Therapy with interferon, thymosin alpha or other immunostimulators within 24 weeks of enrollment (i.e., dosing) into this study
- •Subjects who require chronic administration of concomitant medications which cause immunosuppression or which are associated with a high rate of nephrotoxicity or hepatotoxicity, or which affect renal excretion, should not be enrolled in this study
- •Unable to tolerate oral medication
- •Poor peripheral venous access
- •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
排除标准
- 未提供
研究组 & 干预措施
Arm1
Experimental
干预措施: Entecavir (Drug)
结局指标
主要结局
Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) < 50 IU/mL by Polymerase Chain Reaction (PCR) at Week 48
时间窗: Week 48 of ETV treatment
HBV DNA assessments were performed using the Roche COBAS® TaqMan AmpliPrep assay. HBV DNA \< 50 IU/mL = approximately \<300 copies/mL.
次要结局
- Percentage of Participants Who Achieve HBV DNA < Lower Limit of Quantitation (LOQ = 29 IU/mL [Approximately 169 Copies/mL]) at Week 48(Week 48)
- Percentage of Participants With HBV DNA by PCR Category at Week 48(Week 48)
- Percentage of Participants With Virologic Rebound Through Week 48 While on Continued Dosing With ETV(through Week 48)
- Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48(Week 48)
- Percentage of Participants With Confirmed HBeAg Loss at Week 48 (for HBeAg-positive Participants Only)(Week 48)
- Percentage of Participants With HBeAg Seroconversion at Week 48 (for HBeAg-positive Participants Only)(Week 48)
- Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 48(Week 48)
- Percentage of Participants With HBsAg Seroconversion at Week 48(Week 48)
- Mean log10 Reduction From Baseline in HBV DNA at Week 48(baseline, Week 48)
- Percentage of Participants With HBV DNA < Other IU Cut-off Points That May be Clinically Relevant at the Time of Data Analysis(Week 48)
- Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to Adverse Events(From enrollment through Week 52 + 5 days)
- Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF): Hematology(OT: From start of study therapy through Week 52 + 5 days; OF= End of OT period + 24-week follow-up)
- Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry(OT: From start of study therapy through Week 52 + 5 days; OF= End of OT period + 24-week follow-up)
研究者
研究点 (15)
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