EUCTR2011-000212-25-GB进行中（未招募）1 期
An Open-Label Extension of Study HGT-HIT-045 Evaluating Long-Term Safety and Clinical Outcomes of Intrathecal Idursulfase-IT Administered in Conjunction with Intravenous Elaprase® in Pediatric Patients with Hunter Syndrome and Cognitive Impairment
Shire HGT Inc0 个研究点目标入组 15 人开始时间: 2011年2月24日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
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
- •1Patients must have completed all study requirements and EOS asessments for Study HGT-HIT-045 prior to enrolling in Study HGT-HIT-046 and must have no safety or medical issues that contraindicate participation.
- •2The patient’s parent(s) or legally authorized representative(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 representative(s) and the patient’s assent, as relevant, must be obtained.
- •3The patient has received and tolerated a minimum of 12 months of treatment with weekly IV infusions of Elaprase and has received 80% of the total planned infusions within the last 6 months.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 15
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1The patient is enrolled in another clinical study that involves clinical investigations or use
- •of any investigational product (drug or device) other than the PORT-A-CATH IDDD
- •within 30 days prior to study enrollment or at any time during the study.
- •2The patient is unable to comply with the protocol (eg, is unable to return for safety evaluations, or is otherwise unlikely to complete the study) as determined by the Investigator.
- •3The patient has experienced an adverse reaction to study drug in Study HGT-HIT-045 that contraindicates further treatment with intrathecal idursulfase-IT.
- •4The patient has a known hypersensitivity to any of the components of idursulfase-IT.
- •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 airway compromise 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
- •An additional exclusion criterion for patients who were previously untreated with intrathecal idursulfase-IT in Study HGT-HIT-045:
- •1.The patient has an opening CSF pressure upon lumbar puncture that exceeds 30.0 cm H2O.
研究者
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