ACTRN12606000381583招募中2 期
An Open-Label Study Evaluating the Antiviral Activity of Tenofovir Disoproxil Fumarate (DF) 300mg in Patients with Chronic Hepatitis B Infection and Persistent Viral Replication after Long-Term Therapy with Adefovir Dipivoxil 10mg Daily
Austin Health (investigator initiated)0 个研究点目标入组 60 人开始时间: 2006年8月29日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 ot stated（—）
- 性别
- All
入选标准
- •Male and non-pregnant/non-lactating female HBV infected patients. Patients who are currently receiving adefovir dipivoxil 10 mg daily in combination with lamivudine will be eligible for enrollment. Inclusion criteria include:·Chronic hepatitis B infection defined by positive serum hepatitis B surface antigen (HBsAg) for at least 6 months· Failed lamivudine therapy;· Active chronic hepatitis B infection:o hepatitis B E antigen (HBeAg) negative OR HBeAg positiveo Serum HBV DNA greater or equal to 105 (HBeAg positive) or 104 (HBeAg negative) copies/ml at screening while receiving continuous therapy with adefovir dipivoxil 10mg daily for at least 24 weeks.· Written informed consent.
排除标准
- •Female who is pregnant or breastfeeding;· Female of childbearing potential who is unwilling to use effective contraception method while enrolled in the study;· Decompensated liver disease defined as bilirubin > 1.5 times the upper limit of normal (ULN), prothrombin time (PT) > 1.5 times the ULN, platelets < 75,000/mm3, serum albumin < 30g/l or prior history of clinical hepatic decompensation;· Evidence of hepatocellular carcinoma (alpha-fetoprotein > 50mg/l);· Co-infection with hepatitis C virus (HCV), human immunodeficiency virus (HIV) or hepatitis D virus (HDV);· Significant renal cardiovascular, pulmonary or neurological disease;· The following laboratory values obtained within 30 days prior to study entry:o Creatinine clearance < 70 ml/mino haemoglobin (Hb) < 8g/dlo Leukocytes < 1000mm3.
研究者
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