EUCTR2014-004143-13-GB进行中（未招募）1 期
An Open Label Extension of Study HGT-HIT-094 Evaluating Long Term Safety and Clinical Outcomes of Intrathecal Idursulfase Administered in Conjunction with Elaprase® in Patients with Hunter Syndrome and Cognitive Impairment
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 54
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •1. Subjects must have completed Visit Week 52 assessments in Study HGT-HIT-094
- •2. The subject’s parent(s) or legally authorized guardian(s) 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 parent(s) or legally authorized guardian(s) and the subject’s consent/assent, as relevant, must be obtained
- •3. The subject has continued to receive Elaprase on a regular basis in Study HGT-HIT-094
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 56
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. 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
- •2. The subject has a known hypersensitivity to any of the components of idursulfase-IT
- •3. The subject has clinically relevant intracranial hypertension
- •4. The subject is enrolled in another clinical study, other than HGT-HIT-094, that involves clinical investigations or use of any investigational product (drug or [intrathecal/spinal] device) within 30 days prior to study enrollment or at any time during the study
- •5. The subject has any known or suspected hypersensitivity to anesthesia or is thought to be at an unacceptably high risk for anesthesia due to compromised airways or other conditions.
- •6. The subject has a condition that is contraindicated as described in the SOPH-A-PORT Mini S IDDD Instructions for Use, including:
- •a. The subject has had, or may have, an allergic reaction to the materials of construction of the SOPH-A-PORT Mini S device
- •b. The subject’s body size is too small to support the size of the SOPH-A-PORT Mini S Access Port, as judged by the Investigator
- •c. The subject’s drug therapy requires substances known to be incompatible with the materials of construction
- •d. The subject has a known or suspected local or general infection
- •e. The subject is at risk of abnormal bleeding due to a medical condition or therapy
- •f. The subject has one or more spinal abnormalities that could complicate safe implantation or fixation
- •g. The subject has a functioning CSF shunt device
- •h. The subject has shown an intolerance to an implanted device
研究者
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