An Observational, Long-term Safety Study of TZIELD® (Teplizumab-mzwv) in Patients With Stage 2 Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Sanofi
- 入组人数
- 200
- 试验地点
- 56
- 主要终点
- Number of adverse events (AE) in mothers, fetuses, and infants exposed to TZIELD during pregnancy
研究概览
简要总结
Stage 2 Type 1 Diabates (T1D) is an early stage of T1D characterized by dysglycemia but not yet leading to clinical symptoms. Progression of the disease to Stage 3 (clinical T1D), leads to overt hyperglycemia requiring eventually exogenous insulin.
TZIELD® (teplizumab-mzwv) has been approved to delay onset of stage 3 T1D, by the United States (US) Food and Drug Administration (FDA) for adults and children aged 8 years and older with Stage 2 T1D.
The purpose of this study is to collect general information on patients with stage 2 T1D and further information on the long-term effects of TZIELD® in patients with Stage 2 T1D, treated as per standard of care.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •TZIELD-Exposed Cohort
- •Patients in the US diagnosed with Stage 2 T1D who are planned to initiate TZIELD treatment according to the currently approved label or who have initiated TZIELD treatment within 6 months prior to enrollment:
- •Day 1: 65 mcg/m2
- •Day 2: 125 mcg/m2
- •Day 3: 250 mcg/m2
- •Day 4: 500 mcg/m2
- •Days 5 through 14: 1,030 mcg/m2 per day
- •Cumulative dose is approximately 11,240 mcg/m2
- •Appropriate written informed consent/assent as applicable for the age of the patient
- •TZIELD-Unexposed Cohort
- •Patients in the US diagnosed with Stage 2 T1D but who are not treated with TZIELD
- •Appropriate written informed consent/assent as applicable for the age of the patient
排除标准
- •Patients who initiated TZIELD treatment more than 6 months prior to enrollment
- •Patients who had participated in a previous clinical trial for TZIELD
- •Patients in an ongoing clinical trial of an investigational product or who had ended participation within 6 months prior to study enrollment; patients participating in other observational studies may be enrolled
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Comparator group
Patients not planned to be treated
TZIELD group
Patients prior to the initiation of TZIELD treatment or initiated TZIELD treatment within 6 months to study enrollment
干预措施: TZIELD (teplizumab-mzwv) (Drug)
结局指标
主要结局
Number of adverse events (AE) in mothers, fetuses, and infants exposed to TZIELD during pregnancy
时间窗: From start of pregnancy to 12 months post-partum
Developmental outcomes of the infant
时间窗: From birth of infant to 12 months
Number of adverse events of special interests (AESI)
时间窗: Throughout the study, approximately 10 years
Presence of AESIs including cytokine release syndrome (CRS), serious infections, hypersensitivity reactions, lymphoproliferative disorders, and malignancies
Number of serious adverse events (SAE)
时间窗: Throughout the study, approximately 10 years
Number of maternal pregnancy-related events
时间窗: From start of pregnancy to 12 months post-partum
次要结局
未报告次要终点