NL-OMON54703已完成3 期
An Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn*s Disease - GS-US-419-3896
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Galapagos NV
- 入组人数
- 15
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) Must have the ability to understand and sign a written informed consent form
- •(ICF), which must be obtained prior to initiation of study procedures
- •associated with this trial
- •2) Criterion modified per amendment 9
- •2.1) Must have enrolled in a CD parent protocol, GS-US-4194015, GS-US-419-4016
- •or GS-US-419-3895 or any other Gilead/Galapagos-sponsored filgotinib treatment
- •study for CD
- •3) Females of childbearing potential must have a negative pregnancy test at Day
- •1 and must agree to continued monthly pregnancy testing during use of
- •filgotinib treatment
- •4) Criterion modified per amendment 9
- •4.1) Female subjects of childbearing potential who engage in heterosexual
- •intercourse must agree to use protocol specified method(s) of contraception for
- •the duration described in the protocol
- •5) Willingness to refrain from live or attenuated vaccines during the study and
- •for 12 weeks after last dose of study drug
- •6) Must have completed all required procedures or met protocol specified
- •efficacy discontinuation criteria in a prior filgotinib treatment study for CD
排除标准
- •1) Subjects who are discontinued from a parent study for reasons other than
- •disease worsening or lack of response or remission; eg, subjects who
- •discontinue for safety or tolerability issues are
- •not eligible for this study
- •2) Known hypersensitivity to the study drug
- •3) Any chronic medical condition (including, but not limited to, cardiac or
- •pulmonary disease, alcohol or drug abuse) that, in the opinion of the
- •Investigator or Sponsor, would make the subject unsuitable
- •for the study or would prevent compliance with the study protocol
- •4) Criterion modified per amendment 9
- •4.1) Females who may wish to become pregnant and/or plan to undergo egg
- •donation or egg harvesting for the purpose of current or future fertilization
- •during the course of the study and for at least 30 days after the last dose of
- •5) Criterion deleted per amendment 9
- •6) Criterion deleted per amendment 9
- •6.1) Females of reproductive potential who are unwilling to abide by
- •protocol-specified contraceptive methods as defined in the protocol
- •7) Use of prohibited concomitant medications as outlined in Section 5.4.2
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