EUCTR2013-002245-11-GB进行中（未招募）1 期
ong-term Follow-up of Subjects with Hemoglobinopathies Treated with Ex Vivo Gene Therapy using Autologous Hematopoietic Stem Cells Transduced with a Lentiviral Vector
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 94
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. Provision of written informed consent for this study by subject, or as applicable, subject’s parent(s)/ legal guardian(s).
- •2. Previously treated with drug product for therapy of a hemoglobinopathy in a bluebird bio-sponsored clinical study.
- •3. Able to comply with study requirements
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 14
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •There are no exclusion criteria for this study.
研究者
相似试验
进行中（未招募）
1 期
Study to evaluate long term effect of an experimental approach of gene therapy to treat ß-thalassemia major, know also as transfusion dependent ß-thalassemia, and the sickle cell disease.Subjects treated with gene therapy drug products in a bluebird bio-sponsored study will be invited to participate in this long-term follow-up study to monitor the safety and efficacy of the drug products. To date, subjects in this study have been treated with bluebird bio gene therapy drug products developed to treat the following indications:beta-thalassaemia majorSickle cell diseaseMedDRA version: 20.1Level: LLTClassification code 10055579Term: Sickle-cell beta thalassemiaSystem Organ Class: 100000004850EUCTR2013-002245-11-ITBLUEBIRD BIO, INC.94
进行中（未招募）
1 期
ASubjects treated with gene therapy drug products in a bluebird bio-sponsored study will be invited to participate in this long-term follow-up study to monitor the safety and efficacy of the drug products. To date, subjects in this study have been treated with bluebird bio gene therapy drug products developed to treat the following indications:beta-thalassaemia majorSickle cell diseaseMedDRA version: 20.1Level: LLTClassification code 10055579Term: Sickle-cell beta thalassemiaSystem Organ Class: 100000004850EUCTR2013-002245-11-DEbluebird bio, Inc.94
尚未招募
Unknown
Efficacy and Safety Evaluation of Hemoglobin Control by Erythrocyte Stimulate Agent Recommendation Algorithm in Kidney Failure with Renal Replacement TherapyDiseases of the genitourinary systemKCT0009036Yonsei University Health System, Severance Hospital250
招募中
不适用
The Impact of Hemoglobin Concentration during Hospital Course on Functional Outcome in Acute Ischemic Stroke PatientsDiseases of the nervous systemKCT0000248Seoul National University Bundang Hospital2,800
招募中
不适用
Examination of the perioperative period hemoglobin and a renal function by patient of hepatocellular carcinoma who undergoes intraoperative blood salvage for a extraction operation.hepatocellular carcinomaJPRN-UMIN000012422Kansai Medical University50