An Open-Label Extension for Subjects in Studies HGT-HIT-046 and SHP609-302 Evaluating Long-Term Safety of Intrathecal Idursulfase-IT Administered in Conjunction with Intravenous Elaprase® in Subjects with Hunter Syndrome and Cognitive Impairment - TAK-609-3001

Takeda Development Center Americas Inc.0 个研究点目标入组 8 人开始时间: 2023年10月16日最近更新: 2024年7月22日

适应症

试验速览

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•01. The subject must have completed end of study assessments in studies HGT-HIT-046 or SHP609-302 and received a clinical benefit from idursulfase-IT in the opinion of the investigator., 02. The subject, or subject's legally designated representative, must have been informed of the nature of this open-label extension and must have voluntarily signed an Institutional Review Board (IRB)/ Independent Ethics Committee (IEC) approved informed consent form after all relevant aspects of the study have been explained and discussed. Consent of the subject’s legally designated representative (as applicable) and the subject’s consent/assent, as relevant, must be obtained, 03. The subject has continued to receive Elaprase on a regular basis in studies HGT-HIT-046 or SHP609-302

•01. The subject has experienced, in the opinion of the investigator, a safety or medical issue that contraindicates treatment with idursulfase-IT, including, but not limited to, uncontrolled seizure disorder, bleeding disorder, and clinically relevant hypertension, 02. The subject has clinically relevant intracranial hypertension, 03. The subject is enrolled in another clinical study, other than studies HGT-HIT-046 or SHP609-302, that involves clinical investigations or use of any investigational product (drug or [intrathecal/spinal] device) within 30 days prior to study enrolment or at any time during the study

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