NCT00645736已完成不适用
Study of Acquired Viral Mutations in Chronic Hepatitis B Patients on Antihepadnaviral Therapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 788
- 试验地点
- 1
- 主要终点
- Descriptive statistics for clinical and viral characteristics of the study population
研究概览
简要总结
This study has the aim of describing viral mutation profiles in patients diagnosed with chronic hepatitis B receiving antihepadnaviral therapy.
详细描述
This is a naturalistic cross-sectional study of chronic hepatitis B subjects receiving nucleoside or nucleotide antihepadnaviral therapy.
It is anticipated approximately 800 subjects will be recruited at 20 Australian sites. Data will be collected on the study subjects and analyses performed to describe factors contributing to the emergence of viral mutations in Australian patients with chronic hepatitis B.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Aged 18 years and over
- •Provided informed consent
- •Diagnosis of chronic hepatitis B (HBsAg documented for at least 6 months)
- •Currently prescribed antihepadnaviral therapy (including, but not limited to: lamivudine, adefovir, entecavir, tenofovir or telbivudine) for chronic hepatitis B management
- •Been taking current antihepadnaviral therapy for at least 6 months prior to recruitment
- •Negative tests for HIV Ab, Hepatitis C Ab and Hepatitis D Ab within the previous 2 years
排除标准
- •Known or suspected co-infection with HIV, Hepatitis C or Hepatitis D
- •Concomitant immunosuppression / immunomodulatory therapies
- •Diagnosis of hepatocellular carcinoma where anticipated life expectancy is less than 6 months
- •Current participation in an interventional, blinded, pharmaceutical industry-sponsored clinical trial
- •Current Child Pugh class C classification (current Child Pugh score > 9)
- •Other known or suspected cause of chronic liver disease
- •Any other reason that, in the investigator's opinion, participation in the study would not be in the participant's best interest.
结局指标
主要结局
Descriptive statistics for clinical and viral characteristics of the study population
时间窗: Single timepoint (blood draw)
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Identification of Viral Variants Involved in the Transmission of Hepatitis C and Characterization of Antigenic and Functional Properties of Their Envelope GlycoproteinsHepatitis CNCT02574884University Hospital, Tours8
招募中
不适用
Real World Study of Chronic Viral HepatitisHepatitis, ChronicNCT04025944Huashan Hospital10,000
已完成
不适用
Genome Studies of Hepatocellular Carcinoma Developed in Hepatitis C Patients With Sustained Virological ResponseHepatocellular CarcinomaHepatitis CNCT03254121Karolinska Institutet93
已完成
不适用
Viral Infections in Chronic Obstructive Pulmonary Disease (COPD) ExacerbationsPulmonary Disease, Chronic ObstructiveRespiratory Tract InfectionsVirus DiseasesLung Diseases, ObstructiveNCT00448604University Hospital, Geneva86
招募中
2 期
Treatment Efficacy of Corticosteroids and Mycophenolate Mofetil in Patients With Immune Related HepatitisHepatitis, Drug-InducedNCT04810156Inge Marie Svane60