EUCTR2021-004422-30-DE进行中（未招募）1 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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 47
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. 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.
- •2. Participant is currently benefiting from the treatment with sabatolimab as determined by guidelines of the parent protocol and investigator’s judgment.
- •3. Participant has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements.
- •4. Willingness and ability to comply with scheduled visits, treatment plan and any other study procedures.
- •5. Written informed consent obtained prior to enrolling in the roll-over study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 35
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 11
排除标准
- •1. Participants in cohorts or treatment groups not receiving sabatolimab in the parent protocol.
- •2. Participant has been permanently discontinued from sabatolimab treatment in the parent study due to unacceptable toxicity, non-compliance to study procedures, withdrawal of consent or any other reason.
- •3. 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).
- •4. 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 . For more details see Section 8.4.3
- •5. Participant not willing to comply with the contraception requirements outlined in the exclusion criteria of the parent protocol. For more details see Section 8.4.3.
- •6. Local access to commercially available sabatolimab for parent protocol indications.
研究者
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