EUCTR2009-015985-75-GB进行中（未招募）1 期
An Open-label Extension of Study TKT028 Evaluating Safety and Clinical Outcomes of Replagal Enzyme Replacement Therapy Administered to Adult Patients with Fabry Disease
Shire Human Genetic Therapies (HGT), Inc.0 个研究点目标入组 35 人开始时间: 2011年5月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 35
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
- All
入选标准
- •1. Complete all study requirements and assessments for Study TKT028 less than 30 days (± 7 days) prior to the first dose in this extension protocol.
- •2. Voluntarily signed an Institutional Review Board-/Independent Ethics Committee-approved informed consent form after all relevant aspects of the study have been explained and discussed.
- •3. Has received and tolerated at least 80% of the total planned Replagal infusions in Study TKT028.
- •4. Female patients of child-bearing potential must agree to use a medically acceptable method of contraception at all times during the study and must have a negative pregnancy test at the time of study entry and as required throughout their participation in the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 39
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •1. Has received treatment with any investigational drug (other than Replagal) or device within 30 days prior to study entry.
- •2. 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.
- •3. Has a positive test for hepatitis B surface antigen (HBsAg), hepatitis C (HCV) antibody, or human immunodeficiency virus (HIV) antibody.
- •4. Is pregnant or lactating.
- •5. Is morbidly obese, defined as body mass index (BMI) >39 kg/m2.
- •6. Has any safety or medical issues, as assessed by the Investigator, that contraindicate participation in the study (eg, has experienced an adverse reaction to treatment with Replagal or has a known hypersensitivity to any of the components of Replagal.
研究者
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