NCT00040144终止2 期
A Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Safety and Efficacy of 12 Weeks Oral Treatment With ACH126, 433 (b-L-Fd4C) in Adults With Lamivudine-resistant Chronic Hepatitis B
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 85
- 试验地点
- 18
研究概览
简要总结
The purpose of this study was to determine the safety and antiviral hepatitis B virus (HBV) activity of ACH126, 433 in the treatment of adults with lamivudine-resistant chronic hepatitis B.
详细描述
Evaluation of the safety and antiviral activity of 3 dose levels of ACH126, 433 over a 12-week treatment in the population is described.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic HBV infection, known to be hepatitis B surface antigen (HbsAg) positive ≥ 6 months
- •On lamivudine, either 100 or 150 milligrams daily for the treatment of chronic hepatitis B infection and exhibit a 2-3 log decrease in HBV deoxyribonucleic acid (DNA) levels followed by a rebound of at least 1.5 log HBV DNA or
- •Achieved an HBV DNA level of < 10,000 copies/milliliter (mL) HBV DNA on at least 2 occasions and have rebounded to > 100,000 copies/mL HBV DNA, or
- •Have a demonstrable lamivudine -resistant genotype regardless of treatment history.
- •Hepatitis B e-antigen positive.
- •Human immunodeficiency virus (HIV) negative.
- •Serum alanine aminotransferase ≥ 1.5 and ≤ 10x times the upper limit of normal (ULN).
- •Hemoglobin ≥ 10 grams/deciliter or hematocrit ≥ 30% (in the absence of blood transfusions or erythropoietin treatment in the preceding 2 weeks).
- •Platelet count >75,000/cubic millimeters (in the absence of ongoing granulocyte colony-stimulating factor therapy).
- •Serum creatinine < 1.1x the ULN.
- •Negative radiologic screening test (ultrasound, computerized tomography scan, or magnetic resonance imaging) for hepatocellular carcinoma within 6 months prior to entry.
- •Prothrombin time/international normalize ratio <
- •Participants of reproductive capability must utilize an approved form of birth control.
- •All women of child-bearing capability must have a negative serum or urine pregnancy test (minimum sensitivity of 24 international units/liter of beta human chorionic gonadotropin) within 72 hours prior to the start of study medication.
- •Participants must be able to provide written informed consent.
- •Participant must be available for follow-up for a period of 20 weeks.
排除标准
- •HIV infection.
- •Hepatitis C co-infection.
- •Alcohol abuse.
- •Pregnancy or breast-feeding.
- •Inability to tolerate oral medication.
- •Any clinical condition or prior therapy that, in the Investigator's opinion, would make the participant unsuitable for the study or unable to comply with the dosing requirements.
- •Use of any investigational drug.
- •Participants with decompensated liver disease.
- •Use of any concomitant herbal treatments.
研究者
研究点 (18)
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