NCT06435884进行中（未招募）不适用
Long-Term Follow-up of Adult With Atrophic Scars Treated With TRTP-101 in Study CIC101-01
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- CellinCells
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Serious Adverse Event
研究概览
简要总结
CIC101-01-LT is a long-term follow-up study of subjects treated with TRTP-101 and will evaluate the long-term safety and efficacy of TRTP-101.
详细描述
The long-term safety of TRTP-101 was evaluated by participants in the CIC101-01 clinical trial and followed up for 5 years for serious adverse 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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Received TRTP-101 in clinical trial CIC101-01
- •Provided written informed consent to participate in this study
排除标准
- •Judged to be unsuitable to participate in this long-term follow-up
结局指标
主要结局
Serious Adverse Event
时间窗: Up to 5 years
SAE will be collected
次要结局
- Mean percent change in atrophic scar volume(6, 12, 18 and 24 months)
- Patient's Satisfaction(6, 12, 18 and 24 months)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Extension Study of CTAP101-CL-3001 or CTAP101-CL-3002Hyperparathyroidism, SecondaryVitamin D DeficiencyChronic Kidney DiseaseNCT02282813OPKO Health, Inc.298
已完成
2 期
Safety/Efficacy Study of CTAP101 in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism (SHPT)Secondary HyperparathyroidismVitamin D InsufficiencyChronic Kidney DiseaseNCT01219855OPKO Health, Inc.78
已完成
3 期
Long-term Follow-up Study on Safety and Maintenance of Efficacy of ATX-101Submental FatHealthyNCT02163902Kythera Biopharmaceuticals224
已完成
2 期
Safety and Efficacy of Two Doses of ATIR101, a T-lymphocyte Enriched Leukocyte Preparation Depleted of Host Alloreactive T-cells, in Patients With a Hematologic Malignancy Who Received a Hematopoietic Stem Cell Transplantation From a Haploidentical DonorAcute Myeloid LeukemiaAcute Lymphoblastic LeukemiaMyelodysplastic SyndromeNCT02500550Kiadis Pharma15
已完成
不适用
Long-Term Safety, Tolerability, and Efficacy of DTX101 (AAVrh10FIX) in Adults With Moderate/Severe to Severe Hemophilia BHemophilia BNCT02971969Ultragenyx Pharmaceutical Inc6