NCT07554547已完成不适用
Adakveo® (Crizanlizumab) PRegnancy Outcomes Intensive Monitoring (PRIM)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Proportion of pregnancies resulting in fetal loss
研究概览
简要总结
This was a non-interventional study to evaluate pre-specified pregnancy and infant outcomes in women treated with crizanlizumab during pregnancy or within 105 days before the last menstrual period (LMP).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 16 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All prospective and retrospective pregnancy cases exposed to crizanlizumab during pregnancy or 105 days before LMP reported to the Novartis global safety database were eligible for the PRIM program.
排除标准
- •Cases with the following exclusion criteria were excluded from the crizanlizumab PRIM study:
- •Patients who upon initial case report refuse to be contacted to obtain any FU information. In such cases necessary information using PRIM follow-up checklists cannot be obtained.
- •Indirect cases (reported by someone other than the patient or the healthcare provider (HCP)) for which the reporter refuses to provide FU information and the patient or HCP cannot be identified based on the information provided.
- •Pregnancies of female partners of male patients taking crizanlizumab. Such cases were to be processed as per Manual for Argus Processing (MAP).
- •Cases lacking reporter contact details (e.g., cases from social media) or incomplete cases in which data was missing to allow classification of pregnancy or infant outcomes.
结局指标
主要结局
Proportion of pregnancies resulting in fetal loss
时间窗: Duration of study, up to 56 months
proportion of pregnancies resulting in fetal loss (intrauterine death resulting in stillbirth, spontaneous abortion, or induced termination), among pregnant women exposed to crizanlizumab within 105 days prior to LMP or at any time during pregnancy.
次要结局
- Proportion of major congenital malformations among pregnancies exposed to crizanlizumab(Duration of study, up to 56 months)
- Proportion of overall congenital malformations among pregnancies exposed to crizanlizumab(Duration of study, up to 56 months)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
3 期
Efficacy of certolizumab in women with unexplained recurrent implantation failure: a double-blind randomized controlled trial (CERTIFY)2024-511869-11-00Assistance Publique Hopitaux De Paris161
招募中
4 期
A Study to Evaluate B Cell Levels in Infants Potentially Exposed to Ocrelizumab During Pregnancy - The MINORE Study2024-510974-25-00F. Hoffmann-La Roche AG10
已完成
3 期
Clinical study of Iron supplement in anemic pregnant womenCTRI/2024/07/070773Generex Pharmassist Pvt. Ltd.102
招募中
1 期
A Prospective, Multicenter, Phase Ib/II Trial of Ivonescimab (AK112) Combined With Albumin-Paclitaxel and Cisplatin as Neoadjuvant Therapy for ESCCNCT07385001Tang-Du Hospital45
已完成
不适用
VedAryo® (Vedolizumab) Effectiveness and Safety EvaluationNCT07273760AryoGen Pharmed Co.150