Chronic Lung Disease MedDRA version: 21.1 Level: LLT Classification code 10066204 Term: Chronic lung disease of prematurity System Organ Class: 100000004855
Conditions
Interventions
Product Name: SHP607 (mecasermin rinfabate, rhIGF-1/rhIGFBP-3)
Product Code: SHP607
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Mecasermin rinfabate
CAS Number: 478166-15-3
Current
Sponsors
Premacure AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consents must be signed and dated by the subject's parent(s), if age 16 or older, prior to any study-related procedures. For parent(s) under the age of 16, written informed consents and 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 must be signed and dated by the subject's birth mother, if age 16 or older, prior to any study-related procedures. For birth mothers under the age of 16, written informed consents and assents must be signed and dated by the subject's birth mother and 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: 477 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess the effect of SHP607 on reducing the burden of chronic lung disease (CLD), as indicated by a reduction in time to final weaning off respiratory technology support (RTS) through 12 months corrected age (CA), as compared to a standard neonatal care group.;Secondary Objective: The key secondary objective of this study is to assess the effect of SHP607 on the incidence of bronchopulmonary dysplasia (BPD) PMA 36 weeks (defined by modified NICHD severity grading) or death, as compared to a standard neonatal care group.;Primary end point(s): Time to final weaning off RTS, from Day 1 (ie, randomization) through 12 months CA: o RTS is defined as any one of the following: (1) any fraction of inspired oxygen (FiO2) >21%, (2) noninvasive respiratory support delivered via a nasal interface (e.g., continuous positive airway pressure [CPAP], bilevel positive airway pressure [BiPAP], high flow therapy, nasal intermittent positive pressure ventilation [NIPPV], nasal cannula), (3) invasive respiratory support (mechanical ventilation) via an endotracheal tube or tracheostomy. o During the birth hospitalization, RTS will be recorded daily by site personnel. After NICU discharge, daily RTS will be recorded weekly by parent(s)/caregiver(s), via an electronic device. o The day of final weaning off RTS is defined as the 7th consecutive day off RTS without any further RTS usage through 12 months CA. o Subjects who die before reaching 12 months CA will be considered not to have achieved final weaning off RTS, and will be handled in the primary analysis as a competing event. Subjects who prematurely terminate before 12 months CA will be considered to have achieved final weaning off RTS at the 7th day of no RTS with no return to RTS before premature termination; otherwise the subject will be considered not to have achieved final weaning off RTS, and censored at the date of withdrawal.;Timepoint(s) of evaluation of this end point: | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Chronic respiratory morbidity: o Incidence of BPD (yes/no) (as diagnosed by need for oxygen/respiratory support) at PMA 36 weeks or discharge home, and confirmed by oxygen challenge testing) or death through PMA 36 weeks o Total number of days on RTS from birth through 12 months CA o Duration of rehospitalizations due to respiratory diagnoses through 12 months CA o Number of emergency room visits associated with a respiratory diagnosis through 12 months CA o Number of days of respiratory medication use (eg, bronchodilators, steroids, leukotriene inhibitors, diuretics) through 12 months CA o Incidence of signs and symptoms of respiratory disease (yes/no), as assessed by caregiver-administered 28- day respiratory diaries during the 4 consecutive weeks prior to the 12 month CA visit o Incidence of CRM1 through 12 months CA as measured by respiratory health care utilization. A subject will be defined as having CRM1 if he or she has experienced/required at least 1 of the following 3 clinical/treatment events, as captured by the pulmonary morbidity assessment on at least two 3-month quarters over a 12-month time period. Assessments will be completed weekly by parent(s)/caregiver(s), via an electronic device, from NICU discharge to 12 months CA: 1) Emergency room visit or hospitalization associated with a respiratory diagnosis 2) Home RTS 3) Daily use of respiratory medications (eg, bronchodilators, steroids, leukotriene inhibitors, diuretics) as reported by caregivers on the pulmonary morbidity assessment o Incidence of CRM2 through 12 months CA as measured by respiratory health care utilization and respiratory symptoms. A subject will be defined as having CRM2 if he or she has experienced/required at least 1 of the following 4 clinical/treatment events, as captured by the pulmonary morbidity assessment on at least two 3-month quarters over a 12-month time period. Assessments will be completed weekly by parent(s)/caregiver(s), via an el | — |
Countries
Canada, Finland, France, Germany, Hungary, Ireland, Israel, Japan, Korea, Democratic People's Republic of, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, United Kingdom, United States
Contacts
Public ContactCharlotte Almeida
Shire
Outcome results
None listed