NCT01128686已完成不适用
A Retrospective Cohort Study to Evaluate the Rate of Good Responses to Lamivudine (LAM) Treatment in naïve Chronic Hepatitis B (CHB) Patients With Certain Pre-treatment Characteristics
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Proportion of subjects showing HBV DNA negativity at 5 years of LAM treatment
研究概览
简要总结
This is to evaluate the proportion of subjects who show good responses to LAM treatment in Korea.
详细描述
This is to evaluate the proportion of subjects who show good responses to LAM treatment such as HBV DNA negativity, HBV DNA less than 4 log, no resistant mutation, HBeAg seroconversion and normalization of ALT in naïve CHB patients with certain pre-treatment characteristics, i.e. HBV DNA less than 9log copies per ml and ALT more than 2 times ULN in HBeAg positive subjects, HBV DNA less than 7log copies per ml and elevated ALT in HBeAg negative subjects.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CHB or liver cirrhosis due to Hepatitis B virus who had started LAM between Jan 1, 2003 and Dec 31, 2004 and maintained LAM at least 6 months
- •HBsAg positive at least for 6 months at the beginning of observation
- •HBV DNA positive before LAM administration
- •Subjects with certain pre-treatment laboratory findings as follows; HBV DNA less than 9log copies per ml and ALT more than 2 times ULN in HBeAg positive patients, HBV DNA less than 7log copies per ml and elevated ALT in HBeAg negative patients
排除标准
- •Documented co-infection with HCV, HIV at the beginning of LAM treatment
- •Decompensated liver cirrhosis at the beginning of LAM treatment
- •HCC at the beginning of LAM treatment
结局指标
主要结局
Proportion of subjects showing HBV DNA negativity at 5 years of LAM treatment
时间窗: 5years
次要结局
- Proportion of subjects showing HBV DNA less than 4 log copies per ml during 5 years of LAM treatment(5 years)
- Cumulative proportion of subjects showing HBeAg seroconversion during 5 years of LAM treatment(5 years)
- Proportion of subjects showing HBV DNA negativity during first 4 years of LAM treatment(4 years)
- Proportion of subjects showing ALT normalization during 5 years of LAM treatment(5 years)
- Cumulative proportion of subjects showing resistant mutation during 5 years of LAM treatment(5 years)
- Cumulative proportion of subjects showing HBeAg loss during 5 years of LAM treatment(5 years)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Long-Term Course of Korean Medicine Treatment for Lumbar Disc HerniationLow Back PainIntervertebral Disc DisplacementSciaticaNCT03426215Jaseng Medical Foundation65
已完成
不适用
Impact of Plasma Levels of Colistin in Patients With Carbapenem Resistant Acinetobacter Baumannii InfectionAcinetobacter InfectionsNCT02482961DongGuk University30
已完成
不适用
A retrospective cohort study to evaluate the accuracy of preoperative risk classification of gastrointestinal stromal tumor by endoscopic ultrasound-guided fine needle aspiration biopsy using a 19 gauge needleGISTJPRN-UMIN00001655519 gauge EUS-FNA for GSMT group70
已完成
3 期
Randomized Phase III Study to Evaluate the Efficacy and Safety of Xyzal® (Levocetirizine) vs Zyrtec® (Cetirizine) in Subjects With Dermatitis and EczemaEczemaDermatitisNCT00375713UCB Pharma466
已完成
不适用
Observational Study of C. Diff in Post-Transplant PatientsClostridium DifficileNCT02747017University of Minnesota132