NL-OMON39387已完成3 期
A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057 - HGS1006-C1074
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Have completed the HGS1006-C1056 or HGS1006-C1057 Protocol through the week 72 or week 48 visits, respectively.
- •2. Be able to receive the 1st dose of belimumab for HGS1006-C1074 four weeks (minimum of 2 weeks, maximum of 8 weeks) after the last dose in HGS1006-C1056 or HGS1006 C1057.
排除标准
- •1. Have developed clinical evidence of significant, unstable or uncontrolled, acute or chronic diseases not due to SLE (ie, cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy or infectious diseases), or experienced an adverse event (AE) in the Phase 3 study that could, in the opinion of the principal investigator, put the subject at undue risk.;2. Have developed any other medical diseases (eg, cardiopulmonary), laboratory abnormalities, or conditions (eg, poor venous access) that, in the opinion of the principal investigator, makes the subject unsuitable for the study.
研究者
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