A Clinical Efficacy and Safety Study of SHP607 in Preventing Chronic Lung Disease in Extremely Premature Infants

IDENTIFIERS
Trial Protocol: SHP607-202
Clinicaltrials.gov: NCT03253263
EudraCT: 2018-001393-16
JapicCTI: jRCT2071200076
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.

Recruitment Complete
US
CA
FI
7+
IL
IT
JP
PT
ES
SE
GB

Trial at a glance

What medical condition is being studied?   Retinopathy of Prematurity (ROP), Intraventricular Hemorrhage, Bronchopulmonary Dysplasia, Chronic Lung Disease of Prematurity
What is the trial testing?   SHP607
How many participants are being enrolled?   81
When is the trial being conducted?    - 
How long is participation in the trial?   The total study period will last approximately 15-17 months depending on the participant's GA at birth. Participants enrolled in this study will be asked to participate in a 4-year extension study to evaluate the long-term safety and clinical outcomes of treatment with the study drug.

Key requirements

Sex   
All
Age   
Up to 1 Day
Accepts Healthy Volunteers?   
No

Trial Details / Participation Requirements

CLICK TO EXPANDCLICK TO COLLAPSE
Trial Phase:   Phase 2
Trial Type:   Interventional
Trial Arms/Groups or Cohorts:   
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.
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.
Standard Neonatal Care: Standard neonatal care alone will be provided.
Intervention:   SHP607
Primary Outcome Measure(s):
Time to Final Weaning off Respiratory Technology Support (RTS) From Day 1 Through 12 Months Corrected age (CA) [Time Frame: Baseline through 12 months Corrected Age (CA)]
Secondary Outcome Measure(s):   
Incidence of Bronchopulmonary Dysplasia (BPD) or Death through Postmenstrual age (PMA) 36 Weeks [Time Frame: Baseline through 36 weeks postmenstrual age (PMA)]
Total Number of Days on Respiratory Technology Support (RTS) From Birth Through 12 Months Corrected age (CA) [Time Frame: Birth through 12 months CA]
Duration of Re-hospitalizations [Time Frame: From neonatal intensive care unit (NICU) discharge through 12 months CA]
Number of Emergency Room Visits [Time Frame: From NICU discharge through 12 months CA]
Number of Days of Respiratory Medication use [Time Frame: From NICU discharge through 12 months CA]
Incidence of Signs and Symptoms of Respiratory Disease as Assessed by a 28-day Caregiver-administered Diary Ending at 12 Months Corrected age (CA) [Time Frame: 11 months CA through 12 months CA]
Incidence of Chronic Respiratory Morbidity (CRM1) Through 12 Months Corrected age (CA) [Time Frame: From NICU discharge through 12 months CA]
Incidence of Chronic Respiratory Morbidity Including Symptoms of Respiratory Disease (CRM2) Through 12 Months Corrected age (CA) [Time Frame: From NICU discharge through 12 months CA]
Severity of Chronic Respiratory Morbidity (CRM3) Through 12 Months Corrected age (CA), as Determined by the Chronic Lung Disease (CLD) of Infancy Severity Score [Time Frame: From NICU discharge through 12 months CA]
Incidence of Intraventricular Haemorrhage (IVH) Through Postmenstrual age (PMA) 40 weeks, as Assessed by Cranial Ultrasound [Time Frame: Baseline through 40 Weeks PMA]
Motor Function at 12 Months Corrected age (CA), as Measured by Alberta Infant Motor Scales (AIMS) [Time Frame: At 12 months CA]
Functional Status as Assessed by PREMature Infant Index (PREMII) at Postmenstrual Age (PMA) 36 Weeks [Time Frame: At 36 weeks PMA]
Incidence of Retinopathy of Prematurity (ROP) [Time Frame: 31 weeks through 40 weeks PMA]
Incidence of Mortality [Time Frame: From birth through 12 months CA]
Exposure-response of Insulin-like Growth Factor-1 (IGF-1) [Time Frame: Up to 12 months CA]
Entry Criteria:
Must be newborn preterm infant with gestational age (GA) of 23 weeks +0 days and 27 weeks +6 days. Enrollment into the study has to occur 24 hours after birth. Cannot have known or suspected chromosomal abnormality, genetic disorder, or syndrome.

Trial Locations

Any
Recruiting
Completed
Any
RESULTS
University of South Alabama Children's and Women's Hospital

1700 Center St, Mobile, AL 36604, USA

View on Map
Arkansas Children's Hospital

1 Children's Way, Little Rock, AR 72202, USA

View on Map
University of Arkansas for Medical Sciences

4301 W Markham St, Little Rock, AR 72205, USA

View on Map
LAC USC Medical Center

2051 Marengo St, Los Angeles, CA 90033, USA

View on Map
David Geffen School of Medicine at UCLA

10833 Le Conte Ave, Los Angeles, CA 90095, USA

View on Map
Tampa General Hospital

1 Tampa General Cir, Tampa, FL 33606, USA

View on Map
University of Illinois at Chicago

1200 W Harrison St, Chicago, IL 60607, USA

View on Map
Memorial Hospital of South Bend

615 N Michigan St, South Bend, IN 46601, USA

View on Map
Ochsner Baptist Medical Center

2700 Napoleon Ave, New Orleans, LA 70115, USA

View on Map
Floating Hospital for Children

755 Washington St, Boston, MA 02111, USA

View on Map
University of Mississippi Medical Center

2500 N State St, Jackson, MS 39216, USA

View on Map
Bristol Myers Squibb Children's Hospital at Robert Wood Johnson University Hospital

200 Somerset St, New Brunswick, NJ 08901, USA

View on Map
Vidant Medical Center

2100 Stantonsburg Rd, Greenville, NC 27834, USA

View on Map
University of Oklahoma Health Sciences Center

865 Research Pkwy, Oklahoma City, OK 73104, USA

View on Map
Medical University of South Carolina Children Hospital

171 Ashley Ave, Charleston, SC 29425, USA

View on Map
Virginia Commonwealth University - Children's Hospital of Richmond at VCU

1000 E Broad St, Richmond, VA 23219, USA

View on Map
Sainte Justine Hospital

3175 Chemin de la Côte-Sainte-Catherine, Montréal, QC H3T 1C5, Canada

View on Map
Mount Sinai Hospital

600 University Ave, Toronto, ON M5G 1X5, Canada

View on Map
Oulun Yliopistollinen Sairaala

Kajaanintie 50, 90220 Oulu, Finland

View on Map
Bnai Zion Medical Center

Sderot Eliyahu Golomb 47, Haifa, Israel

View on Map
Fondazione Policlinico Universitario A Gemelli

Via Giuseppe Moscati, 31, 00168 Roma RM, Italy

View on Map
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Via della Commenda, 10, 20122 Milano MI, Italy

View on Map
Azienda Ospedaliera Di Padova

Via Nicolò Giustiniani, 2, 35128 Padova PD, Italy

View on Map
Azienda Ospedaliero-Universitaria Careggi SOD Neonatologia e Terapia Intensiva Neonatale

Largo Piero Palagi, 1, 50139 Firenze FI, Italy

View on Map
Istituto Giannina Gaslini-Istituto Pediatrico di Ricovero e

Via Gerolamo Gaslini, 5, 16147 Genova GE, Italy

View on Map
Presidio Ospedaliero Di Treviso Ca' Foncello

Piazzale dell'Ospedale, 1, 31100 Treviso TV, Italy

View on Map
Kagoshima City Hospital

37-1 Uearatachō, Kagoshima, 890-8760, Japan

View on Map
Nagano Children's Hospital

3100 Toyoshina, Azumino, Nagano 399-8205, Japan

View on Map
Kurashiki Central Hospital

1-chōme-1-1 Miwa, Kurashiki, Okayama 710-8602, Japan

View on Map
Saitama Medical Center

1981番地 Kamoda, Kawagoe, Saitama 350-8550, Japan

View on Map
Osaka Women's and Children's Hospital

840 Murodōchō, Izumi, Osaka 594-1101, Japan

View on Map
Hospital Garcia de Orta

Av. Torrado da Silva, 2805-267 Almada, Portugal

View on Map
Maternidade Alfredo da Costa

R. Viriato 1, 2890-495 Lisboa, Portugal

View on Map
Centro Hospitalar Lisboa

Av. Prof. Egas Moniz MB, 1649-028 Lisboa, Portugal

View on Map
Centro Materno Infantil do Norte - Centro Hospital Universitario do Porto, E.P.E.

Largo da Maternidade de Júlio Dinis 45, 4050-651 Porto, Portugal

View on Map
Hospital Clinico Unversitario de Santiago

Rúa da Choupana, s/n, 15706 Santiago de Compostela, A Coruña, Spain

View on Map
Hospital General Universitario de Alicante

Pintor Baeza, 11, 03010 Alacant, Alicante, Spain

View on Map
Hospital Unversitari de Tarragona Joan XXIII

C/ Dr. Mallafrè Guasch, 4, 43005 Tarragona, Spain

View on Map
Skanes Universitetssjukhus

Entrégatan 7, 222 42 Lund, Sweden

View on Map
Karolinska Solna

Karolinska Vägen, Solna, Sweden

View on Map
Norfolk and Norwich University Hospital

Norfolk & Norwich University Hospital, Colney Ln, Colney, Norwich NR4 7UY, UK

View on Map
Ashford and St. Peter's Hospitals NHS Trust - St. Peter's Hospital

Guildford St, Lyne, Chertsey KT16 0PZ, UK

View on Map
University of Cambridge

The Old Schools, Trinity Ln, Cambridge CB2 1TN, UK

View on Map
University College London

Gower St, Bloomsbury, London WC1E 6BT, UK

View on Map
Chelsea and Westminster NHS Trust

369 Fulham Rd, London SW10 9NH, UK

View on Map
St. Mary's Hospital

Oxford Rd, Manchester M13 9WL, UK

View on Map
Wayne State University Children's Hospital of Michigan

3901 Beaubien St, Detroit, MI 48201, USA

View on Map
Wayne State University Hutzel Women's Hospital

3990 John R St, Detroit, MI 48201, USA

View on Map
Jersey Shore University Medical Center

1945 NJ-33, Neptune City, NJ 07753, USA

View on Map
West Virginia University

Morgantown, WV 26506, USA

View on Map
Aurora Sinai Medical Center

945 N 12th St, Milwaukee, WI 53233, USA

View on Map
View all (51)
Trial Protocol ID: SHP607-202
Back to Trial Summary