2024-515914-41-00招募中2 期
A Phase 2b, Multicenter, Randomized, Open-label, Two-Arm Study to Evaluate the Clinical Efficacy and Safety of OHB-607 Compared to Standard Neonatal Care for the Prevention of Bronchopulmonary Dysplasia, the Most Common Cause of Chronic Lung Disease of Prematurity
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 18
- 主要终点
- Incidence of severe BPD (as defined by the modified NICHD severity grading) or death for all subjects at or before 36 weeks (±3 days) PMA.
研究概览
简要总结
To assess the effect of OHB-607 on reducing the burden of CLD, as indicated by a reduction in the incidence of severe BPD (as defined by the modified NICHD severity grading) at 36 weeks (±3 days) PMA, or death at or before 36 weeks PMA, whichever comes first as compared to the SNC group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 主要目的
- Part B - Observational and non-interventional
- 盲法
- None
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Written informed consents and/or assents must be signed and dated by the subject's parent(s) 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) (in accordance with local regulations).
- •Written informed consents and/or assents must be signed and dated by the subject's birth mother 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 (in accordance with local regulations).
- •Subjects must be between 23 weeks +0 days and 27 weeks +6 days GA, inclusive.
排除标准
- •Detectable major (or severe) congenital malformation identified before randomization.
- •Isolated minor dysmorphic anomalies that are unlikely to be exclusionary could include post-axial polydactyly, ankyloglossia, accessory nipples, preauricular pits, single or horizontal palmar crease, clinodactyly, and single umbilical artery. However, the presence of multiple minor anomalies in the same infant may be exclusionary.
- •Uncomplicated infantile hemangiomas are unlikely to be exclusionary. However, subjects with infantile hemangiomas that may be associated with potential for disfigurement, life-threatening complications, functional impairment, ulceration, or underlying abnormalities should be excluded.
- •Known or suspected chromosomal abnormality, genetic disorder, or syndrome, identified before randomization, according to the investigator’s opinion.
- •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.
- •Clinically significant neurological disease identified before randomization according to cranial ultrasound (CUS) (hemorrhages confined to the germinal matrix are allowed) and investigator’s opinion.
- •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.
- •Current or planned participation in a clinical study of another investigational study treatment, device, or procedure (participation in non-interventional studies is permitted on a case-by-case basis).
- •The subject or subject’s parent(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.
- •Birth mother with active coronavirus disease 2019 (COVID-19) infection at birth or a history of severe COVID-19 infection (requiring intensive care hospitalization) during pregnancy.
- •Major (or severe) congenital malformations include structurally significant congenital heart disease and structural abnormalities of the upper airway, lungs, or chest wall. Congenital malformations that are suspected of being associated with chromosomal abnormalities, genetic syndromes, and neoplasia should be excluded, as well as abnormalities that may affect life expectancy, cardiopulmonary development, neurologic development, or interpretation of study results.
结局指标
主要结局
Incidence of severe BPD (as defined by the modified NICHD severity grading) or death for all subjects at or before 36 weeks (±3 days) PMA.
Incidence of severe BPD (as defined by the modified NICHD severity grading) or death for all subjects at or before 36 weeks (±3 days) PMA.
• No BPD: oxygen for <28 days or none • Mild BPD: need for oxygen for ≥28 days but on room air at 36 weeks PMA • Moderate BPD: oxygen for ≥28 days plus treatment with <30% oxygen at 36 weeks PMA • Severe BPD: oxygen for ≥28 days plus oxygen ≥30% and/or any positive pressure ventilation (CPAP, IMV, NNIMV, or high flow nasal cannula ≥2 L/min) at 36 weeks PMA
• No BPD: oxygen for <28 days or none • Mild BPD: need for oxygen for ≥28 days but on room air at 36 weeks PMA • Moderate BPD: oxygen for ≥28 days plus treatment with <30% oxygen at 36 weeks PMA • Severe BPD: oxygen for ≥28 days plus oxygen ≥30% and/or any positive pressure ventilation (CPAP, IMV, NNIMV, or high flow nasal cannula ≥2 L/min) at 36 weeks PMA
次要结局
- Incidence of all grades of IVH as assessed by centrally read CUS and classified according to the Volpe criteria (Inder et al., 2018).
- Time to final weaning off of RTS from Day 1 of randomization through 12 months CA. The final weaning off of RTS is defined as the 7th consecutive day that the subject is off RTS.
- Incidence of Grade 2 & Grade 3 (severe) BPD (as defined by the modified Jensen severity grading) or death for all subjects at 36 weeks PMA:
- • No BPD: no support • Grade 1: supplemental oxygen <2 L/min without positive pressure (including nasal cannula) • Grade 2: positive pressure support (including CPAP, nasal cannula oxygen ≥2 L/min, NIPPV) • Grade 3: positive pressure ventilation (high-frequency oscillation ventilation and technologies with positive pressure tidal volume breaths, such as IMV
- Incidence of severe (Grade 3 & 4) IVH before 40 weeks PMA (or discharge from/transfer from the NICU, whichever comes first): • Grade 1: blood in the germinal matrix with or without IVH <10% of ventricular space • Grade 2: IVH occupying 10 to 50% of ventricular space on parasagittal view • Grade 3: IVH occupying >50% of ventricle with or without periventricular echo densities • Grade 4: evidence of posthemorrhagic infarction or periventricular echo densities
- Incidence of severe ROP (Stage 3 and above) up to 40 weeks PMA according to International Classification (International Committee for the Classification of Retinopathy of Prematurity, 2021) by local blinded reviewer.
- Respiratory severity scoring will be determined from information captured during follow-up telephone calls and clinical site visits at intervals specified until 12 months CA using CLDPSS (O’Brodovich et al., 2021).
- Neurodevelopmental impairment as determined by the separate BSID III scales at 24 months CA. • Motor composite score • Cognitive composite score • Language composite score
- To be collected through 24 months CA: • Total number of days on RTS in hospital and out of hospital • Number and duration in days of rehospitalizations due to respiratory diagnoses • Number of emergency room visits associated with a respiratory diagnosis • Number of days of respiratory medication use • Respiratory Risk Factors Assessment including breast feeding, vaccines and respiratory syncytial virus prophylaxis, exposure to tobacco, pets, and young children.
- Incidence of severity of all grades of BPD according to the modified NICHD guidelines for preterm infants born at <32 weeks GA, analyzed separately: none, mild, moderate, and severe BPD.
- Incidence of all severity grades of BPD as assessed by Jensen et al., 2019: • No BPD: no support • Grade 1: supplemental oxygen <2 L/min without positive pressure (including nasal cannula) • Grade 2: positive pressure support (including CPAP, nasal cannula oxygen ≥2 L/min, NIPPV) • Grade 3: positive pressure ventilation (highfrequency oscillation ventilation and technologies with positive pressure tidal volume breaths, such as IMV)
- Physical and cognitive development as measured by ASQ-3 administered at 12 and 24 months CA.
- Incidence and severity of all stages of ROP through 40 weeks PMA according to International Classification (International Committee for the Classification of Retinopathy of Prematurity, 2021) by local blinded reviewer.
- Mortality rates from randomization to initial hospital discharge and from initial discharge through 24 months CA.
- Relationships between IGF-1 exposure and respiratory, neurologic, BPD, IVH, NEC, and ROP endpoints.
- • Incidence, severity & causality of AEs & SAEs • Fatal AEs • Changes from baseline in clinical safety lab parameters (primarily blood glucose), physical examination, and vital signs • IV access status • Central line use • Vision and hearing
- • Vision and hearing • Concomitant medications or relevant procedures • Development of anti-IGF-1/IGFBP-3 antibodies (IgG and IgM) • Organ hypertrophy (heart, liver, spleen tonsillar, other organ growth) • Incidence of hemangiomas noted during routine clinical assessments
研究者
Dr. Mark McHale
Scientific
Ohb Neonatology Limited
研究点 (18)
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