An Observational Follow-Up Study of Patients Previously Enrolled in ADR-001-01 Study Against Liver Cirrhosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Number of patients with adverse events (AEs) and serious AEs (SAEs)
研究概览
简要总结
This is a follow-up study to assess safety and preliminary clinical activity of ADR-001 in patients with liver cirrhosis (Child-Pugh score; Grade B) caused by Hepatitis C or Nonalcoholic Steatohepatitis. Patients who have already participated in the ADR-001-01 study and completed the last evaluation after 24 weeks of administration will be eligible to this study.
Patients registered will continue follow-up observation and evaluate long-term safety and exploratory efficacy.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Liver cirrhosis patients enrolled in ADR-001-01 study and completed the last observation of the study
- •Voluntary signed informed consent
排除标准
- •Patients evaluated by investigators as inappropriate
结局指标
主要结局
Number of patients with adverse events (AEs) and serious AEs (SAEs)
时间窗: Change from Baseline (Day 0) until 80 weeks
An AE is any untoward medical event for the patient in the clinical study, associated with study medication. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of hospitalization, results in disability/incapacity, congenital anomaly/birth defect will be evaluated as an SAE.
次要结局
- Change of liver function evaluated by Child-Pugh Score(Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks))
- Improvement rate of Child-Pugh grade(Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks))
- Number of patients with abnormal systolic blood pressure (SBP) and diastolic blood pressure (DBP) findings(Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks))
- Improvement rate of Child-Pugh score(Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks))
- Number of patients with abnormal electrocardiogram (ECG) findings(Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks))
- Number of patients with abnormal urinalysis parameters(Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks))
- Number of patients with abnormal pulse rate findings(Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks))
- Number of patients with abnormal body temperature findings(Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks))
- Number of patients with abnormal clinical chemistry parameters(Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks))
- Number of patients with abnormal clinical hematology parameters(Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks))