Follow-up to Study Protocol B2801001, A Phase I/II, Open-Label Dose Escalation Study to Evaluate the Safety and Efficacy of Single Doses of TT-034 in Patients With Chronic Hepatitis C [CHC] Infection
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Long Term Safety as measured through an assessment of adverse events
研究概览
简要总结
This is a long-term safety follow-up protocol for subjects who received TT-034 under the B2801001 protocol and consists of monitoring for at least 4.5 years.
详细描述
The main purpose of this follow-up study is to detect events suggestive of delayed adverse effects of the study drug by review of clinical histories and discussion with subjects to identify/elicit significant medical events, including but not limited to hematologic, malignant, autoimmune, neurologic, and hepatic events.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Prior enrollment in Study B2801001 and dosing with TT-034
- •An informed consent form for this study signed and dated by the subject or a legally acceptable representative
排除标准
- •There are no specific exclusion criteria for this follow-up study
结局指标
主要结局
Long Term Safety as measured through an assessment of adverse events
时间窗: 4.5 years
The primary objective is to assess the long-term safety of TT-034 administered in subjects with CHC through an assessment of adverse events with a focus on hematologic, malignant, autoimmune, neurologic and hepatic events.
次要结局
- Long Term Viral Load(4.5 years)