EUCTR2021-006776-17-FR进行中（未招募）1 期
An Open-label Study to Evaluate the Long-term Safety of BCX9930 Monotherapy in Subjects with Paroxysmal Nocturnal Hemoglobinuria Who Previously Received BCX9930 in a BioCryst sponsored Study
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
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
- 性别
- All
入选标准
- •1.Able to provide written informed consent.
- •2.Non-pregnant, non-lactating female subjects.
- •3.Subjects with PNH who have completed treatment in another BCX9930 clinical study and, in the opinion of the investigator, would benefit from continued treatment with BCX9930.
- •4.Female participants will continue to meet at least one of the following requirements per the prior study:
- •a.Be a woman of nonchildbearing potential.
- •b.Be a woman of childbearing potential who agrees to use a highly effective contraceptive method throughout the study and for a duration of 30 days after the last dose of BCX9930.
- •c.Alternatively, true abstinence is acceptable for women of childbearing potential when it is in line with the subject’s preferred and usual lifestyle.
- •5.Male participants will continue to meet at least one of the following requirements per the prior study:
- •a.Males with a female partner of childbearing potential (including a pregnant partner) must use condoms throughout the study and for a duration of 90 days after the dose of BCX9930 unless their partner is using a highly effective contraceptive method independent of the study.
- •b.Alternatively, true abstinence is acceptable when it is in line with the subject’s preferred and usual lifestyle.
- •6.In the opinion of the investigator, the subject is expected to adequately comply with all required study procedures and restrictions for the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 180
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1.Any clinically significant medical or psychiatric condition including alcohol or drug dependency that, in the opinion of the investigator or sponsor, would interfere with the subject’s ability to participate in the study or increase the risk of participation for that subject.
- •2.An ongoing adverse event (AE), including a laboratory abnormality, or other unacceptable toxicity that, in the judgment of the investigator, compromises the ability of the subject to continue study-specific procedures or it is considered not to be in the subject’s best interest to continue or benefit-risk assessment is no longer in favor of the subject’s continued treatment.
- •3.Daily use of medications listed in the currently applicable prohibited medications list.
- •4.Known or suspected hypersensitivity to BCX9930 or any of its formulation excipients (Note: prior drug rash is not exclusionary).
研究者
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