A Nationwide Epidemiological, Non-Interventional Study Evaluating an Educational Support Program for Improving Treatment Adherence in Patients With Hepatitis B Viral Infection
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Hepatitis B treatment adherence rate in patients with support system
研究概览
简要总结
Protocol Title: A Nationwide Epidemiological, Non-Interventional Study Evaluating an Educational Support Program for Improving Treatment Adherence in Patients with Hepatitis B Viral Infection
Objective(s): The primary objectives of the study are to assess:
- HBV treatment adherence rate in patients enrolled in the Support Program
- Adherence rates at 6m, 12m.
The secondary objectives are to assess:
- Adverse events rate and profile.
- Actual treatment duration and dose taken vs. prescribed.
- The impact of SMS reminders.
Study Design: Eligible patients will be randomized into one of four groups: Group 1 shall receive both a weekly phone call from a supporter and a daily SMS reminder. Group 2 will receive a weekly phone call only. Group 3 will receive a daily SMS reminder only and group 4 (Control) shall receive no support.
Study Population: Adult newly diagnosed with Hep B patients, eligible to begin treatment with first line therapy.
Data Collection Methods:
- Supporter's documentations of patient's self assessment.
- Drugs dispense data from pharmacies
- Pills count.
详细描述
Protocol Number: AI463-972 Date: 23-Oct-2013 Ver: 2 Observational Study Protocol AI463-972 - Help-B
A Nationwide Epidemiological, Non-Interventional Study Evaluating an Educational Support Program for Improving Treatment Adherence in Patients with Hepatitis B Viral Infection
Prof. Eli Zuckerman; Dr. Yoram Menachem; Prof. Rifat Safadi; Prof. Assy Nimer; Dr. Rawi Hazzan; Dr. Michal Carmiel
Treatment for Chronic HBV The objectives of HBV therapy are to improve upon the spontaneous rates of sustained disease remission (as defined by long-term HBeAg and HBsAg seroconversion rates off-treatment), thereby reducing the risk of disease progression, with resultant improvements in quality of life and reductions in healthcare costs. Seven drugs are presently approved in the USA and/or EU for the treatment of CHB in patients with HBeAg-positive and -negative disease. They fall into 2 classes: antiviral/immunomodulators (IFNα and pegIFNα-2a) and antiviral nucleos(t)ide analogs (NUCs).
EASL and AASLD Treatment Guidelines (2009) recommend that HBV therapy may be initiated with any of the currently approved agents, but that IFNα (standard or pegylated), Tenofovir (TDF) or Entecavir (ETV) are preferred first-line options for treatment of CHB patients with HBeAg-positive and HBeAg-negative disease.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male and female patient (> 18 years).
- •Prescribed treatment of Entecavir for HBV
- •Must have access to a smart-phone.
- •Written informed consent.
排除标准
- •• Patients with hepatitis C, hepatitis D or HIV co-infection.
- •Co-infected patients who require additional medication.
- •Patients with prior liver transplantation
- •Patients with impaired renal function requiring dialysis
- •Immune-suppressed patients receiving HBV antiviral prophylaxis
- •Pregnant patients.
- •Inability or unwillingness to provide informed consent or abide by the requirements of the study.
- •Parallel participation in another clinical trial.
- •Patients who cannot take medication independently.
结局指标
主要结局
Hepatitis B treatment adherence rate in patients with support system
时间窗: 6 months
次要结局
未报告次要终点
研究者
Eli Zuckerman
Director of Liver Unit
Carmel Medical Center