临床试验/NCT06506773

NCT06506773已完成不适用

A Natural History Study of Exocrine Pancreatic Function in Infants With Cystic Fibrosis Less Than 12 Months of Age

Vertex Pharmaceuticals Incorporated50 个研究点分布在 11 个国家目标入组 79 人开始时间: 2024年7月9日最近更新: 2025年12月31日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Vertex Pharmaceuticals Incorporated
入组人数: 79
试验地点: 50
主要终点: Proportion of Participants with FE-1 greater than or equal to (≥) 200 microgram per gram (µg/g) Over Time

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of the study is to evaluate the natural history of exocrine pancreatic function by assessing Fecal elastase-1 (FE-1) in infants with CF during their first year of life.

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: — 至 6 Months（Child）
性别: All
接受健康志愿者: 否

入选标准

•Participants with CF less than (<) 6 months of age at the index date
•Participants not eligible to receive commercial Kalydeco™ (based on local product labels) and are not receiving Kalydeco or any other cystic fibrosis transmembrane conductance regulator gene (CFTR) modulator

排除标准

•Participant whose mother took any CFTR modulator while pregnant with the participant, or who has any history of exposure to a CFTR modulator
•Other protocol defined Inclusion/Exclusion criteria apply.

结局指标

主要结局

Proportion of Participants with FE-1 greater than or equal to (≥) 200 microgram per gram (µg/g) Over Time

时间窗: From Enrollment up to the Infant turning 12 Months of Age

次要结局

FE-1 level Over Time(From Enrollment up to the Infant turning 12 Months of Age)

研究者

发起方

Vertex Pharmaceuticals Incorporated

申办方类型

Industry

责任方

Sponsor

研究点 (50)

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