NCT02258581终止不适用
A Long Term Follow-up Registry of Subjects Treated in A Gilead-Sponsored Trial in Subjects With Chronic Hepatitis B Infection
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 241
- 试验地点
- 35
- 主要终点
- Proportion of participants with serum hepatitis B surface antigen (HBsAg) decline ≥ 0.5 log10 IU/ml from baseline at Week 48
研究概览
简要总结
This study will evaluate the long term effects of hepatitis B virus (HBV) treatment on the HBV serologic changes and HBV DNA levels through Week 144. This registry will enroll only individuals who were treated in a Gilead-sponsored trial for chronic hepatitis B (CHB).
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
- •Must have participated in a Gilead-sponsored chronic hepatitis B (CHB) study no more than 120 days prior to Baseline (Day 1), except for participants from previous Gilead-sponsored study number GS-US-174-0149, who will have up to one year from their last visit in that protocol.
- •Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
- •Must be willing and able to comply with the visit schedule and study requirements
- •Must have documented HBV DNA < 2,000 IU/mL at time of screening visit, which shall occur no later than 1 year post last study visit in GS-US-174-0149
- •Must have documented hepatitis B surface antigen (HBsAg) negative status anytime during participation in GS-US-174-0149 regardless of ongoing HBV treatment
排除标准
- •Patient participating or planning to participate in another clinical study with an investigational agent
- •History of clinically-significant illness or any other major medical disorder that may interfere with follow-up, assessments or compliance with the protocol
- •Believed by the Study Investigator to be inappropriate for study participation for any reason not otherwise listed
- •Received TDF monotherapy either as part of GS-US-174-0149 Arm C (TDF monotherapy arm) or for TDF retreatment, and have taken any HBV antiviral therapy since completion of GS-US-174-0149
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
结局指标
主要结局
Proportion of participants with serum hepatitis B surface antigen (HBsAg) decline ≥ 0.5 log10 IU/ml from baseline at Week 48
时间窗: Week 48
This endpoint will be measured for participants who are HBsAg positive at baseline.
Proportion of participants who remain HBsAg negative at Week 48
时间窗: Week 48
This endpoint will be measured for participants who are HBsAg negative at baseline.
次要结局
- Proportion of participants who remain HBsAg negative at Week 144(Week 144)
- Proportions of participants who remain HBeAg negative and hepatitis B envelope antibody (HBeAb) positive at Week 48(Week 48)
- Proportions of participants who remain HBeAg negative and HBeAb positive at Week 144(Week 144)
- Change from Baseline in HBV DNA at Weeks 48, 96, and 144(Baseline; Week 48; Week 96; Week 144)
- Proportion of participants with serum HBsAg decline ≥ 0.5 log10 IU/ml from baseline at Week 144(Week 144)
- Proportion of participants with HBV DNA < the lower limit of quantitation (LLOQ) at Weeks 48, 96 and 144(Weeks 48, 96 and 144)
- Proportions of participants with hepatitis B envelope antigen (HBeAg) loss and seroconversion at Week 48(Week 48)
- Proportion of participants who achieve HBsAg loss at Weeks 48 and 144(Weeks 48, 144)
- Proportions of participants with HBeAg loss and seroconversion at Week 144(Week 144)
研究者
研究点 (35)
Loading locations...
相似试验
招募中
不适用
Therapeutic Effects and Long-term Follow-up After Ending Nucleos(t)Ide Analogs Therapy in Chronic Hepatitis bChronic Hepatitis bNCT02883647Third Affiliated Hospital, Sun Yat-Sen University100
已完成
4 期
Long Term Follow-Up Study 16-20 Years After Hepatitis B Vaccination in Newborns of Mothers Who Were Seropositive for Hepatitis B Envelope Antigen (HBeAg) & Hepatitis B Surface Antigen (HBsAg)Hepatitis BNCT00240539GlaxoSmithKline36
Unknown
不适用
A Cohort Study on Long-term Clinical Outcomes of Antiviral Therapy in Patients With Chronic Hepatitis B and CirrhosisChronic Hepatitis bNCT04301908Beijing Ditan Hospital10,000
招募中
不适用
Long-Term Follow-up Study for Subjects With CHB Previously Treated With Imdusiran (AB729)Long Term Follow-upNCT06277037Arbutus Biopharma Corporation50
Unknown
4 期
Influence of Antiviral Treatment to the Long-Term Prognosis of Patients With Chronic HBV InfectionHepatitis B, ChronicNCT00810524Sun Yat-sen University600