A Prospective, Observational, Single-center Post-marketing Surveillance Study of Telbivudine in Chronic Hepatitis B Adults With HBeAg Positive/Negative.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- HBV-DNA < 300 Copies/mL in 48 Weeks
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability and antiviral efficacy of telbivudine by maintained suppression of hepatitis B virus (HBV) DNA (<=300 copies/ml or 60IU/ml, undetectable by current polymerase chain reaction (PCR) - based assays) in HBeAg positive/negative patients at physician's general practice.
详细描述
Primary objective: To evaluate the antiviral efficacy of telbivudine by maintained suppression of HBV DNA(<=300 copies/ml or 60 IU/ml,undetectable by current PCR-based assays) in HBeAg positive patients from Week 24 to Week 48.
Methodology: This will be an open-label, prospective, observational, single-center and single arm post marketing surveillance study.
Number of patients: It is estimated to enroll 240 intent-to-treat patients in Taiwan.
Population: Male or female patients, at least 18 years of age diagnosed with chronic hepatitis B with liver disease and telbivudine is prescribed by physicians based on clinical justification. And patients are able to communicate well, provide written informed consent, and willing to participate in the entire study.
研究设计
- 研究类型
- Observational
- 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 or female, at least 18 years of age.
- •Documented chronic hepatitis B defined by all of the following:
- •Clinical history compatible with chronic hepatitis B.
- •Detectable serum hepatitis B surface antigen >= 6 months at screening visit, with either HBeAg positive or negative.
- •Willing and able to comply with the observational drug regimen and all other study requirements.
- •Willing and able to provide written informed consent to participate in the study.
排除标准
- •Females who are pregnant,intending to become pregnant or breast feeding.
- •Patients with co-infection with hepatitis C virus, hepatitis D virus or human immunodeficiency virus.
- •Patients with hypersensitivity to telbivudine or to any of the excipients.
- •One or more known primary or secondary causes of liver disease other than hepatitis B (e.g., alcoholism, steatohepatitis, autoimmune hepatitis, hemochromatosis, alpha-1 anti-trypsin deficiency, Wilson's disease, other congenital or metabolic conditions affecting the liver, congestive heart failure or other severe cardiopulmonary disease). Gilbert's syndrome and Dubin-Johnson syndrome will not exclude patients from participation in this trial.
- •Enrolled or planning to be enrolled in another clinical trial of an investigational agent while participating in this study.
- •Unable to receive safety and tolerability assessments.
结局指标
主要结局
HBV-DNA < 300 Copies/mL in 48 Weeks
时间窗: 48 weeks
次要结局
未报告次要终点