HBRN: Immune Regulation and Costimulation in Natural History and Therapeutic Outcome of Chronic Hepatitis B
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 8
- 主要终点
- Immune regulatory and effector responses relative to HBV DNA, ALT and clinical outcome
研究概览
简要总结
This is an ancillary to the NIDDK-sponsored treatment trials titled: Combination Therapy of Pegylated Interferon Alfa-2a and Tenofovir Versus Tenofovir Monotherapy in Chronic Hepatitis B (NCT01369212) and Combination Entecavir and Peginterferon Therapy in HBeAg-Positive Immune-Tolerant Adults With Chronic Hepatitis B (NCT01369199).
This study will examine the balance between immune regulatory and effector responses in hepatitis B-infected participants enrolled in the HBRN's clinical trials (NCT01369212 and NCT01369199) to define natural history and treatment outcome.
详细描述
Aim 1. Therapeutic HBV suppression will enhance antiviral immune effector responses and reduce immune inhibitory factors in participants with chronic hepatitis B. This study will also examine if antiviral therapy has a durable effect in host immune phenotype and define the immunological effect of interferon-alpha (IFNα) therapy in chronic HBV participants.
Aim 2. Antiviral immune effector and regulatory responses before, during and/or after therapy can predict long term therapeutic response.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Ability to provide informed consent for participation in the ancillary study
排除标准
- •Children under 18 years of age
- •Pregnant women
- •Participants with anemia (Hgb<10 or Hct<30)
- •Participants with active medical conditions such as congestive heart failure or chronic lung disease requiring oxygen, active coronary artery disease with unstable angina, sepsis and renal failure
- •Participants with significant medical conditions, autoimmune disease or immunosuppression
结局指标
主要结局
Immune regulatory and effector responses relative to HBV DNA, ALT and clinical outcome
时间窗: up to 192 weeks
HBV-specific lymphoproliferative, IFN-gamma and IL10 responses, T cell activation and costimulatory markers ( PD1, CTLA4, CD28, CD127), FoxP3+ Treg frequency, and NK frequency and expression of activating/inhibitory receptors Dendritic cell frequency
次要结局
未报告次要终点
研究者
Kyong-Mi Chang
Professor, Gastroenterology
University of Pennsylvania