2024-516543-26-00招募中3 期
A Multicenter, Multinational Extension of Study PRV-031-001 to Evaluate the Long-Term Safety of Teplizumab (PRV-031), a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Children and Adolescents with Recent-Onset Type 1 Diabetes Mellitus
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 16
- 主要终点
- Incidence of adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs), including infections and malignancies
研究概览
简要总结
To evaluate the long-term safety of teplizumab in participants who previously completed the PRV-031-001 (PROTECT) study for an additional 42 months of follow-up
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 years 至 64 years（18-64 Years, 0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Completion of the PRV-031-001 (PROTECT) study by completing the Week 78 visit in that study, regardless of how many doses of study drug were administered
- •Provide written informed consent within 12 months of the Week 78 in the PRV- 031-001 study. Written assent will be obtained for participants under 18 years of age at the time of enrollment, according to applicable regulations. If possible, written informed consent and/or assent for the current PROTECT Extension study (PRV-031-003) should be obtained at the final (Week 78) visit in the PROTECT study
排除标准
- •Premature discontinuation from the PRV-031-003 (PROTECT) study for any reason
结局指标
主要结局
Incidence of adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs), including infections and malignancies
Incidence of adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs), including infections and malignancies
次要结局
- The area under the time-versus-concentration curve (AUC) of C-peptide after a 4-hour (4h) mixed-meal tolerance test (MMTT), a measure of endogenous insulin production and β cell function
- Insulin use, defined as a daily average dose in units per kilogram per day (U/kg/day)
- HbA1c levels
研究者
Clinical Sciences and Operations
Scientific
Provention Bio Inc.
研究点 (16)
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