NCT03597633Unknown不适用
Tenofovir-based Combination Therapy or Monotherapy for Multi-drug Resistant Chronic Hepatitis B; Real World Data From Multicenter Cohort Study
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 236
- 试验地点
- 1
- 主要终点
- Virologic Response
研究概览
简要总结
Treatment of multidrug resistant (MDR) chronic hepatitis B (CHB) is still a challenging issue. Hence, the investigators will perform a multicenter prospective cohort study for the evaluation of tenofovir disoproxil fumarate (TDF)-based therapy for MDR CHB at real life settings.
详细描述
Inclusion criteria were CHB patients with resistance to more than two classes of nucleos(t)ide analogues (NA) and hepatitis B virus (HBV) DNA level ≥200 IU/mL.
Patients will receive either TDF-base combination therapy or TDF monotherapy. The primary end point is virologic response (VR) defined by an undetectable HBV DNA (<20 IU/mL) at month 36.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CHB patients with:
- •documented HBsAg positivity at least 6 months before enrollment
- •age >18 years old,
- •confirmed genotypic resistance to more than two classes of NAs
- •HBV DNA level ≥ 200 IU/mL
- •compensated liver diseases (defined by Child-Pugh-Turcotte score <7; prothrombin time <3 seconds above upper limit of normal or international normalized ratio <1.5; serum albumin >3 g/dL; total bilirubin <2.5 mg/dL; no history of esophago-gastric variceal bleeding, ascites, over hepatic encephalopathy)
- •willingness to give an informed consent.
排除标准
- •laboratory abnormalities of low serum phosphorous level <2.0 mEq/dL, elevated serum creatinine >1.5 mg/dL, decreased creatinine clearance rate <50 mL/min, absolute neutrophil count <1000 cell/mL, or low hemoglobin level <10 g/dL (if female, <9 g/dL)
- •no definite evidence of genotypic resistance
- •positive antibody test for hepatitis C virus, hepatitis D virus, or human immunodeficiency virus
- •a proof of pregnant or lactating women
- •evidence of active alcohol consumption (140 g per a week for men and 70 g per a week for women)
- •any untreated malignancy.
结局指标
主要结局
Virologic Response
时间窗: 36 months
undetectable HBV DNA (\<20 IU/mL)
次要结局
- ALT normalization(36 months, 60 months)
- mean HBV DNA(36 months, 60 months)
- Genotypic resistance(36 months, 60 months)
- Virologic Response(60 months)
- virologic breakthrough(36 months, 60 months)
- Hepatitis B e antigen (HBeAg) seroconversion(36 months, 60 months)
研究者
研究点 (1)
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