EUCTR2018-001393-16-IT进行中（未招募）1 期
A Phase 2b, Multicenter, Randomized, Open-label, Controlled, 3-Arm Studyto Evaluate the Clinical Efficacy and Safety of SHP607 in Preventing ChronicLung Disease Through 12 Months Corrected Age Compared to StandardNeonatal Care in Extremely Premature Infants - SHP607-202
PREMACURE AB, A MEMBER OF SHIRE GROUP OF COMPANIES0 个研究点目标入组 600 人开始时间: 2021年1月28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
- 600
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. Written informed consents and/or assents must be signed and dated
- •by the subject's parent(s) or legally authorized representative(s), if
- •applicable, prior to any study-related procedures. The informed consent
- •and any assents for underage parents must be approved by the
- •institutional review board (IRB)/independent ethics committee (IEC).
- •2. Written informed consents and/or assents must be signed and dated
- •by the subject's birth mother or her legally authorized representative(s),
- •if applicable, prior to providing study-related information related to birth
- •mother medical history, pregnancy and the birth of the subject. The
- •informed consent and any assents for underage birth mothers must be
- •approved by the IRB/IEC.
- •XML File Identifier: elrCJttlaCTVeNuyT5tKPfNNMns=
- •3. Initially, subjects must be between GA of 26 weeks +0 days and 27
- •weeks +6 days, inclusive. After approximately 75 subjects
- •(approximately 25 subjects in each treatment group) have completed
- •the PMA 40 weeks visit, an independent DMC will assess safety data and
- •may authorize enrollment of subjects of GA between 23 weeks +0 days
- •and 27 weeks +6 days, inclusive.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Detectable major (or severe) congenital malformation identified
- •before randomization.
- •2. Known or suspected chromosomal abnormality, genetic disorder, or
- •syndrome, identified before randomization, according to the
- •investigator's opinion.
- •3. Hypoglycemia at Baseline (blood glucose <45 mg/dL or 2.5 mmol/L)
- •which persists in spite of glucose supplementation, to exclude severe
- •congenital abnormalities of glucose metabolism.
- •4. Clinically significant neurological disease identified before
- •randomization according to cranial ultrasound (hemorrhages confined to
- •the germinal matrix are allowed) and
- •investigator's opinion.
- •5. Any other condition or therapy that, in the investigator's opinion, may
- •pose a risk to the subject or interfere with the subject's potential
- •compliance with this protocol or interfere with interpretation of results.
- •6. Current or planned participation in a clinical study of another
- •investigational study drug, device, or procedure (participation in
- •observational studies is permitted on a case-by-case basis).
- •7. The subject or subject's parent(s) or legally authorized
- •representative(s) is/are unable to comply with the protocol or is unlikely
- •to be available for long-term follow-up as determined by the
- •investigator.
研究者
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