An Open-label Extension Study to Evaluate the Long-term Safety of Inclacumab Administered to Participants with Sickle Cell Disease Who Have Participated in an Inclacumab Clinical Trial

Global Blood Therapeutics Inc.0 个研究点目标入组 520 人开始时间: 2021年5月16日最近更新: 2023年5月29日

研究概览

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•Inclusion Criteria Participants who meet all the following criteria will be eligible for study enrollment:
•1. Male or female participant with SCD who participated and received study drug in a GBT-Sponsored inclacumab clinical study.
•2. Participant has completed the originating inclacumab study within 30 days prior to the Day 1 Visit. Participants who discontinued study drug in the originating study due to a non-study drug-related adverse event (AE), but who remained on study, may be eligible for treatment in this study provided the AE does not pose a risk for treatment with inclacumab.
•3. Female participants of childbearing potential are required to have a negative urine pregnancy test prior to dosing on Day 1. Note: Female participants who become childbearing during the study must be willing to have a negative urine pregnancy test to remain in the study.
•4. If sexually active, female participants of childbearing potential must use highly effective methods of contraception until 165 days after the last dose of study drug. If sexually active, male participants must use barrier methods of contraception until 165 days after the last dose of study drug.
•5. Participant has provided written informed consent/assent. For underage participants, both the consent of the participant’s legal representative or legal guardian and the participant’s assent (where applicable) must be obtained based on local requirement.

•Exclusion Criteria Participants meeting any of the following exclusion criteria will not be eligible for study enrollment:
•1. Female participant who is breastfeeding or pregnant.
•2. Participant had an infusion-related reaction (IRR) in the originating inclacumab clinical study.
•3. Participant withdrew consent from the originating inclacumab clinical study.
•4. Participant was lost to follow-up from the originating inclacumab clinical study.
•5. Participant has any medical, psychological, safety, or behavioral conditions that, in the opinion of the Investigator, may confound safety interpretation, interfere with compliance, or preclude informed consent.

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