EUCTR2014-004143-13-FR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. Patients must have completed Visit Week 52 assessments in Study HGT-HIT-094
- •2. The patient’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 patient’s parent(s) or legally authorized guardian(s) and the patient’s assent, as relevant, must be obtained
- •3. The patient 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: 54
- •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 patient 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 patient has a known hypersensitivity to any of the components of idursulfase-IT
- •3. The patient has clinically relevant intracranial hypertension
- •4. The patient 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 patient 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 patient has a condition that is contraindicated as described in the SOPH-A-PORT Mini S IDDD Instructions for Use, including:
- •a. The patient has had, or may have, an allergic reaction to the materials of construction of the SOPH-A-PORT Mini S device
- •b. The patient’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 patient’s drug therapy requires substances known to be incompatible with the materials of construction
- •d. The patient has a known or suspected local or general infection
- •e. The patient is at risk of abnormal bleeding due to a medical condition or therapy
- •f. The patient has one or more spinal abnormalities that could complicate safe implantation or fixation
- •g. The patient has a functioning CSF shunt device
- •h. The patient has shown an intolerance to an implanted device
研究者
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