NCT02338674已完成1 期
Combination Therapy of Tenofovir and Telbivudine in Immune-tolerant Patients With Chronic Hepatitis B Awaiting Assisted Reproduction
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Percentage of Participants With HBV DNA < 500 Copies/mL at Week 12
研究概览
简要总结
Immune-tolerant patients with chronic hepatitis B (CHB) awaiting assisted reproduction (AR) are required to initiate antiviral therapy due to laboratory safety. Additionally, rapid virus elimination is suggested to faciliate timely performance of AR. However, no consensus is reached regarding the antiviral therapy in this group. This study aimed to explore the efficacy and safety of tenofovir (TDF) and telbivudine (LdT) in this population.
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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 18-45 years old with artificial reproductive needs
- •Liver function (ALT) <40U/L for male and <30 for female
- •HBV-DNA> 10e+5
- •History> 0.5 years
排除标准
- •Cirrhosis
- •Combined with other liver diseases such as autoimmune liver disease, alcoholic liver disease, fatty liver
- •Liver or other parts of malignancies
- •Bilirubin> 17.1
- •GGT> 2ULN
- •Liver transplant patients
- •combined HCV, HDV, HIV infection
- •A history of anti-HBV drug resistance
- •History of habitual abortion
- •previous fetal malformation history
- •CRP> 3.0ng / ml
- •Uncontrolled hypertension
- •Proteinuria or Calculated creatinine clearance < 70 mL/min
- •Heart failure or acute coronary syndrome
- •Coagulopathy
- •Drug or alcohol addiction
- •Hyperlipidemia LDL> 4.6 or TG> 2.0
- •Alphafetoprotein > 50 ng/mL
- •Received interferon (pegylated or not) therapy within 6 months of the screening visit
- •Evidence of hepatocellular carcinoma
- •Received solid organ or bone marrow transplantation
- •Was currently receiving therapy with immunomodulators (eg, corticosteroids, etc.), investigational agents, nephrotoxic agents, or agents
- •Known hypersensitivity to the study drugs, the metabolites, or formulation excipients
研究组 & 干预措施
COM
Experimental
COM group receives combination therapy of tenofovir and telbivudine (TDF and LdT) for at least 48 weeks
干预措施: Tenofovir and telbivudine (Drug)
TDF
Active Comparator
TDF group receives single therapy of tenofovir (TDF) for at least 48 weeks
干预措施: Tenofovir (Drug)
结局指标
主要结局
Percentage of Participants With HBV DNA < 500 Copies/mL at Week 12
时间窗: week 12
次要结局
- Occurrence of HBV Resistance Mutations(Baseline to Week 48)
- Fetal Malformations Occurrence(week 26 of pregnancy)
- Number of Participants With Normal Alanine Aminotransferase (ALT) at Week 12, 24, 36 and 48(Week 12, 24, 36 and 48)
- Number of Participants With Seroconversion to Antibody to HBsAg (AntiHBs) at Week 12, 24, 36 and 48(Week 12, 24, 36 and 48)
- Percentage of Participants With HBV DNA < 500 Copies/mL at Week 24, 36 and 48(Week 24, 36 and 48)
- Number of Participants With Seroconversion to Antibody Against HBeAg (AntiHBe) at Week 12, 24, 36 and 48(Week 12, 24, 36 and 48)
- Number of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 12, 24, 36 and 48(Week 12, 24, 36 and 48)
- Down syndrome Occurrence(week 13 of pregnancy)
- Number of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 12, 24, 36 and 48(Week 12, 24, 36 and 48)
- off-treatment recurrence of HBV(Week 72 to 96)
研究者
Dongliang Li
Director, Department of Hepatobiliary Disease
Fuzhou General Hospital
研究点 (1)
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