2024-515281-14-00招募中2 期
An open-label, multicenter, roll-over study for patients who have completed a prior Novartis-sponsored sabatolimab (MBG453) study and are judged by the investigator to benefit from continued treatment with sabatolimab
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 14
- 主要终点
- Frequency and severity of AEs and SAEs
研究概览
简要总结
To evaluate safety, including SAE and AE
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 years 至 65+ years（65+ Years, 0-17 Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Participant is currently enrolled in a Novartis-sponsored study with sabatolimab, is being treated with sabatolimab, and has fulfilled all requirements in the parent study.
- •Participant is currently benefiting from the treatment with sabatolimab as determined by guidelines of the parent protocol and investigator's judgment.
- •Participant has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements.
- •Willingness and ability to comply with scheduled visits, treatment plan and any other study procedures.
- •Written informed consent obtained prior to enrolling in the roll-over study.
排除标准
- •Participants in cohorts or treatment groups not receiving sabatolimab in the parent protocol.
- •Participant has been permanently discontinued from sabatolimab treatment in the parent study due to unacceptable toxicity, noncompliance to study procedures, withdrawal of consent or any other reason.
- •Participant currently has unresolved toxicities for which sabatolimab dosing has been interrupted in the parent study (participants meeting all other eligibility criteria may be enrolled once toxicities have resolved to allow sabatolimab dosing to resume).
- •Pregnant or nursing (lactating) women. Where pregnancy is defined as the state of a female after conception confirmed by a positive serum hCG laboratory test and until the termination of gestation.
- •Participant not willing to comply with the contraception requirements outlined in the exclusion criteria of the parent protocol.
- •Local access to commercially available sabatolimab for parent protocol indications.
结局指标
主要结局
Frequency and severity of AEs and SAEs
Frequency and severity of AEs and SAEs
次要结局
- Duration of exposure to sabatolimab
研究者
Novartis Pharma Arzneimittel GmbH
Scientific
Novartis Pharma AG
研究点 (14)
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