跳至主要内容
临床试验/NCT02755194
NCT02755194终止不适用

"Drugs in Lactation" Analysis Consortium (DLAC)

The Hospital for Sick Children1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2014年9月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
68
试验地点
1
主要终点
Drug levels in breast milk

研究概览

简要总结

Some medications taken by the breastfeeding women are excreted into milk, posing a potential risk of toxicity to the infant. The first line of evidence required for toxicity risk assessment is prediction of drug levels in milk. However, pharmacokinetic (PK) information of drug excretion into milk is largely lacking, or limited to data from case reports. This makes it difficult to provide population-level prediction of drug levels in milk. The lack of data on this topic jeopardizes not only maternal adherence to drug therapy during breastfeeding but also establishment of breastfeeding, even if the drug is considered safe during nursing. Clearly, this clinical problem in drug safety is an important women's health issue, affecting both mother and infant. "Drugs in Lactation" Analysis Consortium (DLAC) is a "drug-in-milk" monitoring network, which is designed as a platform for efficient collection of patient milk samples in a real world setting to generate population predictions of drug excretion levels into human milk.

详细描述

OVERARCHING GOAL OF DLAC:

To establish a post-marketing "drug-in-milk" monitoring system for nursing women who are prescribed and using medications. Drugs in Lactation Analysis Consortium (DLAC) will provide risk assessment data and tools for toxicity detection in the form of population estimates and variations of drug levels in mother's milk and infant plasma for several common medications in a real world setting.

SPECIFIC OBJECTIVES:

  • To generate data on drug levels in breast milk
  • To develop a population pharmacokinetic model describing drug levels in milk
  • To simulate/predict drug levels in milk in a population, based on the pop PK model
  • To develop a physiologically-based pharmacokinetic (PBPK) model describing drug levels in infant serum
  • To screen the breastfed infants of mothers on the study drugs for general health condition (medical issues, developmental milestones)

SCOPE AND RATIONALE:

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age over 18 years old Taking one or more drugs of interest of the study, at steady state

排除标准

  • Being unable to communicate in English, Colostrum phase (<1 week postpartum)

结局指标

主要结局

Drug levels in breast milk

时间窗: Through the study completion, an average of 4 years

Robust parameter estimates from pop PK modelling usually require samples from \>30-50 individuals. Therefore, an average of 4 years is considered as the time frame, so that the required numbers of samples for each drug can be collected for population PK analysis and modelling.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shinya Ito

Division Head, Senior Scientist

The Hospital for Sick Children

研究点 (1)

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