CTRI/2019/07/020217招募中1 期
Boost to Brittle Bones - BOOST2B
Department of Biotechnology0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
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
- •Children diagnosed with OI type III or severe OI type IV
- •1.Clinical and molecular diagnosis of OI in the child (Glycine substitution in the collagen triple-helix encoding region of either the COL1A1 or COL1A2 gene)
- •1.Patient between 1-4 year of age
- •2.Bisphosphonate (BP) treatment initiated before inclusion
- •3.Parent/authorized representative over 18 years of age
- •4.Ability of the parent/authorized representative to give informed consent
排除标准
- •1.Signs of fever or infections 24 hours before infusion
- •2.Existence of other disorder that might interfere with the treatment (such as severe malformations, hypoxic encephalopathy (l-lll), neurological problems, immune deficiencies muscle diseases, syndromes
- •3.Abnormal karyotype
- •4.Any psychological, familial, sociological and/or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
研究者
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