CTRI/2009/091/000322已完成3 期
An Open-Label Extension Study of Gene-Activated® Human Glucocerebrosidase (GA-GCB) Enzyme Replacement Therapy in Patients With Type 1 Gaucher Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 102
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Inclusion Criteria: 1. The patient has completed study TKT032 or TKT034, or study HGT-GCB-039. 2. 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 negative results to a pregnancy test performed at the time of enrollment and as
- •required throughout their participation in the study. 3. Male patients must agree to use a medically acceptable
- •method of contraception at all times during the study and report a partner's pregnancy to the investigator. 4.
- •The patient, the patient's parent(s) or legal guardian(s) has provided written informed consent that has been
- •approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC). 5. The patient must be
- •sufficiently cooperative to participate in this clinical study as judged by the Investigator
排除标准
- •Exclusion Criteria: 1. The patient has received treatment with any non-Gaucher disease-related investigational drug or device within the
- •30 days prior to study entry; such use during the study is not permitted. 2. The patient is pregnant or lactating.
- •3. The patient, patients parent(s), or patients legal guardian(s) is/are unable to understand the nature, scope,
- •and possible consequences of the study. 4. The patient has a significant comorbidity(ies) that might affect study
- •data or confound the study results (e.g., malignancies, primary biliary cirrhosis, autoimmune liver disease, etc.).
- •5. The patient is unable to comply with the protocol, e.g., has a clinically relevant medical condition making
- •implementation of the protocol difficult, has an uncooperative attitude, is unable to return for safety evaluations,
- •or is otherwise unlikely to complete the study, as determined by the Investigator
研究者
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