NCT05017662已完成不适用
A Multicentre Surveillance Study to Evaluate the Long-term Safety in Participants Who Have Been Previously Treated With 177Lu-IPN01072 in an Ipsen-sponsored Clinical Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 14
- 主要终点
- Proportion of participants with second primary haematological and non-haematological malignancies.
研究概览
简要总结
The purpose of the protocol is to evaluate the long-term safety of medicine 177Lu-satoreotide tetraxetan (also known as 177Lu-IPN01072 or 177Lu-OPS201) for patients who have previously received 177Lu-satoreotide tetraxetan in the clinical study OPS-C-001 / D-FR-01072-001.
详细描述
The study qualifies as interventional not because of the use of an investigational product, but because the imposed specific data collection includes assessments/blood collection and on-site visits not necessarily part of routine clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Participant is capable of giving signed informed consent
- •Participant must have received at least one infusion of 177Lu-IPN01072 in Study OPS-C-001
排除标准
- •- There are no exclusion criteria in this safety surveillance study.
结局指标
主要结局
Proportion of participants with second primary haematological and non-haematological malignancies.
时间窗: During the whole study period (approximately 5 years).
次要结局
- Proportion of treatment-related adverse events of any grade.(During the whole study period (approximately 5 years).)
- Changes over time in laboratory tests (biochemistry)(During the whole study period (approximately 5 years).)
- Changes over time in laboratory tests (haematology)(During the whole study period (approximately 5 years).)
- Overall survival defined as the time from the first dose of 177Lu-IPN01072 until death from any cause.(During the whole study period (approximately 5 years).)
研究者
研究点 (14)
Loading locations...
相似试验
尚未招募
不适用
Long-term Follow-up Study to Evaluate the Safety and Explore the Efficacy of Multiple Doses of FURESTEM-AD InjAtopic DermatitisNCT04730024Kang Stem Biotech Co., Ltd.102
已完成
2 期
An Extension Study to Evaluate the Long-Term Safety and Durability of Effect of LUM001 in the Treatment of Cholestatic Liver Disease in Subjects With Alagille Syndrome (ALGS)Alagille SyndromeNCT02047318Mirum Pharmaceuticals, Inc.19
已完成
3 期
Open-label Extension Study to Evaluate Long-term Safety of Sacubitril/Valsartan in Pediatric Patients With HFHeart FailureNCT03785405Novartis Pharmaceuticals216
已完成
3 期
An Extension Study Investigating the Efficacy and Safety of a Fast-Dissolving ("Melt") Formulation of Desmopressin for the Treatment of Nocturia in AdultsNocturiaNCT00615836Ferring Pharmaceuticals554
终止
3 期
Long-Term Extension Study in Participants With Multiple Sclerosis Who Have Completed Study 205MS301 (NCT01064401) to Evaluate the Safety and Efficacy of BIIB019Relapsing-Remitting Multiple SclerosisMultiple SclerosisNCT01797965Biogen1,501