NCT00736190已完成4 期
A Phase IV Study to Evaluate the Efficacy, Safety and Tolerability of Tenofovir DF in Asian-American Adults With Chronic Hepatitis B Infection
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 主要终点
- Number of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <400 Copies/mL (<69 IU/mL)
研究概览
简要总结
The purpose of this study is to evaluate the antiviral activity and safety of tenofovir disoproxil fumarate (TDF) in Asian-American adults (self-reported Asian descent, living in the United States) with chronic hepatitis B infection. All participants will receive active treatment with TDF for 48 weeks.
详细描述
Efficacy of TDF will be evaluated for reductions in serum HBV DNA, changes in liver enzymes, and the generation of antibody to the virus. Safety will be assessed by evaluating adverse events, laboratory abnormalities, and the development of drug resistance mutations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female
- •Asian-American, defined as a person of self-reported Asian ancestry who is residing in the United States (US)
- •18 through 75 years of age, inclusive
- •Documented chronic HBV infection, defined as positive serum HBsAg =/> 6 months
- •HBV DNA =/> 10,000 copies/mL (PCR method)
- •ALT > ULN and </= 10 × ULN at screening or within the past 12 months prior to screening
- •Willing and able to provide written informed consent
- •Negative serum beta-human chorionic gonadotropin (HCG) pregnancy test (females of child-bearing potential)
- •Estimated glomerular filtration rate (creatinine clearance) =/> 60 mL/min/1.73m^2 by the Cockcroft-Gault equation
- •Adequate hematologic function (absolute neutrophil count =/> 1,500/mm^3; hemoglobin =/> 10.0 g/dL)
- •No prior TDF therapy; participants may have taken < 12 weeks of oral anti-HBV therapy, with the last dose =/> 16 weeks prior to screening; participants may have received prior interferon, but must have discontinued interferon therapy =/> 6 months prior to screening
排除标准
- •Participants who meet any of the following exclusion criteria are not to be enrolled in this study.
- •Pregnant women, women who are breast feeding or who believe they may wish to become pregnant during the course of the study.
- •Males and females of reproductive potential who are not willing to use an effective method of contraception during the study. For males, condoms should be used and for females, a barrier contraception method should be used in combination with one other form of contraception.
- •Decompensated liver disease defined as direct (conjugated) bilirubin > 1.2 X ULN, prothrombin time (PT) > 1.2 X ULN, platelets < 150,000/mm3, or serum albumin < 3.5 g/dL
- •Prior history of clinical hepatic decompensation (eg, ascites, jaundice, encephalopathy) or variceal hemorrhage
- •Receipt of prior TDF treatment
- •Receipt of =/> 12 weeks of oral anti-HBV nucleoside/nucleotide therapy, or receipt of ANY oral anti-HBV treatment < 16 weeks prior to screening
- •Receipt of interferon (pegylated or not) therapy within 6 months of the Screening Visit
- •alpha-fetoprotein > 50 ng/mL
- •Evidence of hepatocellular carcinoma (HCC)
- •Co-infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis D virus (HDV)
- •History of significant renal disease (eg, nephrotic syndrome, renal dysgenesis, polycystic kidney disease, congenital nephrosis, acute tubular necrosis, other renal disease)
- •History of significant bone disease (eg, osteomalacia, chronic osteomyelitis, osteogenesis imperfecta, osteochrondroses, multiple bone fractures)
- •Significant cardiovascular, pulmonary or neurological disease
- •Evidence of a gastrointestinal malabsorption syndrome that may interfere with absorption of orally administered medications
- •History of solid organ or bone marrow transplantation
- •Ongoing therapy with any of the following: nephrotoxic agents, competitors of renal excretion (eg, probenecid), systemic chemotherapeutic agents, systemic corticosteroids, Interleukin-2 (IL-2) and other immunomodulating agents, investigational agents (except with the expressed approval of the Sponsor); administration of any of the above medications must be discontinued at least 30 days prior to the Baseline Visit and for the duration of the study period
- •Known hypersensitivity to the study drugs, the metabolites, or formulation excipients
- •Any other condition (including alcohol or substance abuse) or prior therapy that, in the opinion of the Investigator, would make the participant unsuitable for the study or unable to comply with dosing requirements
研究组 & 干预措施
TDF
Experimental
300-mg tablet (marketed formulation) taken orally once daily
干预措施: Tenofovir disoproxil fumarate (Drug)
结局指标
主要结局
Number of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <400 Copies/mL (<69 IU/mL)
时间窗: Week 48
Blood samples were collected from study participants for measuring HBV DNA via polymerase chain reaction (PCR) method.
次要结局
- Number of Participants With Alanine Aminotransferase (ALT) Normal at Week 48(Week 48)
- Number of Participants With ALT Normalized (Baseline Values > ULN [34 U/L] and <= ULN at a Subsequent Visit) at Week 48(Week 48)
- Number of Participants With Composite Endpoint of Hepatitis B Virus (HBV) DNA <400 Copies/mL (<69 IU/mL) and Normal ALT at Week 48(Week 48)
- Change From Baseline in FibroTest Value(Baseline and Week 48)
- Number of Participants With HBeAg/Hepatitis B Surface Antigen (HBsAg) Loss and Seroconversion(Week 48)
- Number of Participants With HBV DNA < 169 Copies/mL (<29 IU/mL) at Week 48(Week 48)
- Number of Participants With Composite Endpoint of HBV DNA <400 Copies/mL (<69 IU/mL), Normal ALT, and HBeAg Loss(Week 48)
- Number of Participants With Composite Endpoint of HBV DNA <400 Copies/mL (<69 IU/mL), Normal ALT, and Seroconversion to Anti-HBe(Week 48)
- Summary of Resistance Surveillance for Participants Without Virologic Breakthrough(Week 48)
- Summary of Resistance Surveillance for Participants With Virologic Breakthrough(Week 48)
- Summary of Resistance Surveillance for Participants Who Discontinued the Study Early(Week 48)
研究者
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