Purpose

The purpose of this study is to determine if an investigational drug can reduce the burden of chronic lung disease in extremely premature babies through 12 months corrected age (CA), as compared to extremely premature babies receiving standard neonatal care alone.

Conditions

Eligibility

Eligible Ages
Under 1 Day
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Written informed consents and/or assents must be signed and dated by the participant'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).
  2. Written informed consents and/or assents must be signed and dated by the participant's birth mother prior to providing study-related information related to birth mother medical history, pregnancy and the birth of the participant. The informed consent and any assents for underage birth mothers must be approved by the IRB/IEC.
  3. Initially, participants must be between gestational age (GA) of 26 weeks +0 days and 27 weeks +6 days, inclusive. After approximately 75 participants (approximately 25 participants in each treatment group) have completed the postmenstrual age (PMA) 40 weeks visit, an independent data monitoring committee (DMC) will assess safety data and may authorize enrollment of participants of GA between 23 weeks +0 days and 27 weeks +6 days, inclusive.

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 less than (<) 45 milligrams per deciliter [mg/dL] or 2.5 milli moles per liter [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 participant or interfere with the participant'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 participant or participant'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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
SHP607 250 mcg/kg/24 hours
Participants will receive continuous intravenous (IV) infusion of SHP607 250 micrograms per kilogram per 24 hours (mcg/kg/24 hours) from birth up to postmenstrual age (PMA) 29 weeks +6 days.
  • Drug: SHP607
    Participants will receive intravenous infusion of SHP607 at doses of 250 mcg/kg/24 hours and 400 mcg/kg/24 hours from birth up to PMA 29 weeks + 6 days.
    Other names:
    • Mecasermin Rinfabate
Experimental
SHP607 400 mcg/kg/24 hours
Participants will receive continuous IV infusion of SHP607 400 mcg/kg/24 hours through from birth up to PMA 29 weeks +6 days.
  • Drug: SHP607
    Participants will receive intravenous infusion of SHP607 at doses of 250 mcg/kg/24 hours and 400 mcg/kg/24 hours from birth up to PMA 29 weeks + 6 days.
    Other names:
    • Mecasermin Rinfabate
No Intervention
Standard Neonatal Care
Standard neonatal care alone will be provided.

Recruiting Locations

University of South Alabama Children's and Women's Hospital
Mobile, Alabama 36604
Contact:
Site Contact
251-415-1055; 251-451-1270

Arkansas Children's Hospital
Little Rock, Arkansas 72202-3500
Contact:
Site Contact
501-364-2596

University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Contact:
Site Contact
501-526-7984

David Geffen School of Medicine at UCLA
Los Angeles, California 90095
Contact:
Site Contact
310-794-8864; 310-825-9330

Tampa General Hospital
Tampa, Florida 33606
Contact:
Site Contact
813-844-3437

University of Illinois at Chicago
Chicago, Illinois 60612
Contact:
Site Contact
312-355-4038

Memorial Hospital of South Bend
South Bend, Indiana 46601
Contact:
Site Contact
574-647-3048

Ochsner Baptist Medical Center
New Orleans, Louisiana 70115
Contact:
Site Contact
504-894-2619; 504-842-4832

University of Mississippi Medical Center
Jackson, Mississippi 39216
Contact:
Site Contact
601-815-3070

Jersey Shore University Medical Center
Neptune, New Jersey 07753
Contact:
Site Contact
(732) 776-4693, (732) 776-4287

Bristol Myers Squibb Children's Hospital at Robert Wood Johnson University Hospital
New Brunswick, New Jersey 08901
Contact:
Site Contact
732-235-5691

University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
Contact:
Site Contact
405-271-5215

Medical University of South Carolina Children Hospital
Charleston, South Carolina 29425
Contact:
Site Contact
843-792-8829

Virginia Commonwealth University - Children's Hospital of Richmond at VCU
Richmond, Virginia 23219
Contact:
Site Contact
804-828-9602; 804-628-3921

West Virginia University
Morgantown, West Virginia 26506
Contact:
Site Contact
304-293-1202
mpolak@hsc.wvu.edu

Aurora Sinai Medical Center
Milwaukee, Wisconsin 53233
Contact:
Site Contact
414-828-3708

More Details

NCT ID
NCT03253263
Status
Recruiting
Sponsor
Shire

Study Contact

Shire Contact
+1 866 842 5335
ClinicalTransparency@shire.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.