NCT01356901已完成不适用
Persistence, Adherence and Clinical Effectiveness in Patients With Chronic Hepatitis B Viral Infection Treated With Entecavir in Real Life
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2011年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Percentage of Chronic hepatitis B (CHB) patients treated with Entecavir (ETV) and any switch or add-on therapy who are persistent over a time period of two years in a real-life setting.
研究概览
简要总结
The purpose of this observational study is to measure the real-life persistence, adherence and clinical effectiveness of entecavir in patients with chronic Hepatitis B viral infection.
详细描述
Sampling Method: Probability Sample (consecutive patient sampling)
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female treatment naïve or pre-treated CHB patients of at least 18 years of age
- •Written informed consent
排除标准
- •All relevant conditions according to Summary of product characteristics (SmPC)
- •Human immunodeficiency virus (HIV), Hepatitis C virus (HCV) or Hepatitis D virus (HDV) co-infection
- •Patients currently included in any investigational trial on CHB
结局指标
主要结局
Percentage of Chronic hepatitis B (CHB) patients treated with Entecavir (ETV) and any switch or add-on therapy who are persistent over a time period of two years in a real-life setting.
时间窗: After 2 years
A patient will be defined as non-persistent if he misses all his doses in more than 30 subsequent days or if he fails to show up at more than one subsequent visit.
次要结局
- Reasons for therapy non-persistence (therapy discontinuation) and low therapy adherence (qualitative questionnaire for causal assessment of non-persistence/non-adherence)(After 2 years)
- Number of participants with occuring resistances based on results from resistance tests(After 2 years)
- Assessment of Health Status (SF-12® Health Survey)(Assessment of Health Status (SF-12 Health Survey) at year 2)
- Adherence rates using administrative measures (continuous multiple-interval medication gaps, continuous single interval medication availability), and self-report measures, 8-item self-report Morisky Medication Adherence Scale (MMAS)(After 2 years)
- Proportion of patients with HBV DNA below the limit of detection (according to local lab standard), mean log reduction of HBV DNA from baseline, proportion of subjects with normal ALT and with e antigen (eAg)/Surface antigen (sAg) seroconversion/loss(After 2 years)
- Frequency of Serious adverse drug reaction ((S)ADR)s and study discontinuations due to (S)ADRs(After 2 years)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Comparative Analysis of Adherence and Effectiveness Outcomes Between Rheumatoid Arthritis (RA) Patients Treated With Tofacitinib Modified Release (MR)Rheumatoid ArthritisNCT04018001Pfizer1,057
已完成
不适用
Study for the Recording of Adherence to Treatment With Perindopril/Indapamide/Amlodipine Fixed Dose CombinationAdherence to Medication RegimeHypertensive DiseaseNCT02655029Servier Hellas Pharmaceuticals Ltd.2,285
已完成
不适用
A Study to Assess Persistence, Adherence and Changes in Disease Activity in the Children Population of Juvenile Arthritis Patients Treated With Adalimumab (HUMIRA®)Polyarticular Juvenile ArthritisNCT03383263AbbVie70
终止
不适用
Study of Diroximel Fumarate in the Real-World SettingRelapsing Forms of MSNCT04746976Biogen75
终止
不适用
Exploring Diroximel Fumarate Real-world Experience in Canada and IsraelRelapsing Forms of MSNCT04948606Biogen64