A Phase 2b, Multicenter, Randomized, Open-label, Controlled, 3-Arm Study to Evaluate the Clinical Efficacy and Safety of SHP607 in Preventing Chronic Lung Disease Through 12 Months Corrected Age Compared to Standard Neonatal Care in Extremely Premature Infants

Premacure AB, A Member of the Shire Group of Companies0 个研究点目标入组 600 人开始时间: 2019年7月11日最近更新: 2020年3月18日

研究概览

暂无简介。

•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.
•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: 600
•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

•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.

发起方

Premacure AB, A Member of the Shire Group of Companies