CTRI/2016/11/007454招募中Unknown
A Long Term Follow-up Registry of Subjects Treated in AGilead-Sponsored Trial in Subjects with Chronic Hepatitis BInfection
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 7
- 试验地点
- 4
- 主要终点
- 1. For subjects who are HBsAg positive at Baseline:The proportion of subjects with serum HBsAg decline ≥ 0.5 log10 IU/ml from Baseline at
研究概览
简要总结
The purpose of this study is to evaluate a long term follow-up of subjects with Chronic Hepatitis B Infection at Baseline and at Week 12,24,48,72,96,120,144.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Must have participated in a Gilead-sponsored CHB study no more than 120 days prior to Baseline (Day 1), except for subjects 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 HBsAg negative status anytime during participation in GS-US-174-0149 regardless of ongoing HBV treatment.
- •1.Patient participating or planning to participate in another clinical study with an investigational agent 2.History or current presence of clinically-significant illness or any other major medical disorder that may interfere with subject follow-up, assessments or compliance with the protocol.
- •3.Believed by the Study Investigator to be inappropriate for study participation for any reason not otherwise listed.
- •For subjects from previous Gilead-sponsored study number GS-US-174-0149 meeting Inclusion Criteria #4, subjects who meet the following exclusion criteria are not eligible to participate in the study:
- •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.
排除标准
- •1.Patient participating or planning to participate in another clinical study with an investigational agent 2.History or current presence of clinically-significant illness or any other major medical disorder that may interfere with subject follow-up, assessments or compliance with the protocol.
- •3.Believed by the Study Investigator to be inappropriate for study participation for any reason not otherwise listed.
- •For subjects from previous Gilead-sponsored study number GS-US-174-0149 meeting Inclusion Criteria #4, subjects who meet the following exclusion criteria are not eligible to participate in the study:
- •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.
结局指标
主要结局
1. For subjects who are HBsAg positive at Baseline:The proportion of subjects with serum HBsAg decline ≥ 0.5 log10 IU/ml from Baseline at
时间窗: Week 48
2. For subjects who are HBsAg negative at Baseline:The proportion of subjects who remain HBsAg negative at Week 48
时间窗: Week 48
Week 48.
时间窗: Week 48
次要结局
- .The proportion of subjects with serum HBsAg decline ≥ 0.5 log10 IU/ml from Baseline at Week 144.(2.The proportion of subjects who achieve HBsAg loss at week 48, 144.)
研究者
研究点 (4)
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