First In Human Study on Synthetic Surfactant CHF 5633 in Respiratory Distress Syndrome
Primary Purpose
Respiratory Distress Syndrome in Premature Infants
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
synthetic surfactant (CHF5633)
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Distress Syndrome in Premature Infants focused on measuring Respiratory Distress syndrome, Complications of prematurity
Eligibility Criteria
Inclusion Criteria:
- Written informed consent obtained by parents/legal representative (according to local regulation) prior to any study-related procedures
- Inborn and outborn, preterm neonates of either sex with a gestational age of 27 weeks up to 33 weeks+6
- Clinical and radiological findings typical of RDS
- Age on admission to the study < 24 hours from birth
- Requirement of endotracheal intubation for surfactant administration
- Fraction of inspired oxygen (FiO2) > 0.35 to maintain SpO2 between 90-95 %
- Documentation of normal cranial ultrasound scan
Exclusion Criteria:
- Use of surfactant prior to study entry and need for intratracheal administration of any other treatment (e.g. nitric oxide)
- Known genetic or chromosomal disorders, major congenital anomalies (cardiac malformations, myelomeningocele etc)
- Maternal drug abuse (heroin, methadone, methamphetamine, or cocaine) or significant alcohol consumption during pregnancy
- Clinical chorioamnionitis (Appendix III)
- Strong suspicion of congenital pneumonia/infection, sepsis
- Evidence of severe birth asphyxia or a 5 minutes Apgar score less / equal 3
- Presence of air leaks prior to study entry
- Neonatal seizures prior to study entry
- Mothers with prolonged rupture of the membranes (> 3 weeks duration)
- Any condition that, in the opinion of the Investigator, would place the neonate at undue risk
- Participation in another clinical trial of any placebo, drug or biological substance conducted under the provisions of a protocol
Sites / Locations
- Liverpool Women's Hospital Neonatal Unit Liverpool Women's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Synthetic Surfactant
Arm Description
Cohort Design
Outcomes
Primary Outcome Measures
Monitoring of adverse events following CHF5633 administration
Secondary Outcome Measures
CHF 5633 efficacy profile (oxygenation , ventilatory requirements and need for rescue surfactant treatment),systemic absorption and immunogenicity assesment
Full Information
NCT ID
NCT01651637
First Posted
April 20, 2012
Last Updated
July 30, 2020
Sponsor
Chiesi Farmaceutici S.p.A.
1. Study Identification
Unique Protocol Identification Number
NCT01651637
Brief Title
First In Human Study on Synthetic Surfactant CHF 5633 in Respiratory Distress Syndrome
Official Title
A First in Human Clinical Study on the Safety and Tolerability of Two Escalating Single Doses of CHF 5633 (Synthetic Surfactant) in Preterm Neonates With Respiratory Distress Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
January 23, 2015 (Actual)
Study Completion Date
January 23, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chiesi Farmaceutici S.p.A.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study is to investigate the safety and tolerability of intratracheal administration of two different single doses of CHF 5633 in preterm neonates with RDS in terms of adverse events, adverse drug reactions, hematology and biochemistry values, the incidence of major neonatal morbidities including bronchopulmonary dysplasia (BPD) and mortality.
Detailed Description
The study will be a multicentre, open-label, single escalating dose, per-cohort design.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome in Premature Infants
Keywords
Respiratory Distress syndrome, Complications of prematurity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Synthetic Surfactant
Arm Type
Experimental
Arm Description
Cohort Design
Intervention Type
Drug
Intervention Name(s)
synthetic surfactant (CHF5633)
Intervention Description
CHF5633 100 mg/kg; CHF5633 200 mg/kg synthetic surfactant sterile suspension in 3.0 ml glass vials with a total concentration of 80 mg/ml for intratracheal administration. Single administration
Primary Outcome Measure Information:
Title
Monitoring of adverse events following CHF5633 administration
Time Frame
For duration of hospital stay (expected average of 9 weeks)
Secondary Outcome Measure Information:
Title
CHF 5633 efficacy profile (oxygenation , ventilatory requirements and need for rescue surfactant treatment),systemic absorption and immunogenicity assesment
Time Frame
At min 30, at hrs 1, 3, 6, 12, 24, at days 2, 3, 7 and at days 10, 28, at 36 weeks pma post dosing for ventilatory requirements, at pre-dose and 3 hrs and 24 hrs post dosing for systemic absorption and at 8 wks after administration for immunogenicity
10. Eligibility
Sex
All
Minimum Age & Unit of Time
27 Weeks
Maximum Age & Unit of Time
34 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Written informed consent obtained by parents/legal representative (according to local regulation) prior to any study-related procedures
Inborn and outborn, preterm neonates of either sex with a gestational age of 27 weeks up to 33 weeks+6
Clinical and radiological findings typical of RDS
Age on admission to the study < 24 hours from birth
Requirement of endotracheal intubation for surfactant administration
Fraction of inspired oxygen (FiO2) > 0.35 to maintain SpO2 between 90-95 %
Documentation of normal cranial ultrasound scan
Exclusion Criteria:
Use of surfactant prior to study entry and need for intratracheal administration of any other treatment (e.g. nitric oxide)
Known genetic or chromosomal disorders, major congenital anomalies (cardiac malformations, myelomeningocele etc)
Maternal drug abuse (heroin, methadone, methamphetamine, or cocaine) or significant alcohol consumption during pregnancy
Clinical chorioamnionitis (Appendix III)
Strong suspicion of congenital pneumonia/infection, sepsis
Evidence of severe birth asphyxia or a 5 minutes Apgar score less / equal 3
Presence of air leaks prior to study entry
Neonatal seizures prior to study entry
Mothers with prolonged rupture of the membranes (> 3 weeks duration)
Any condition that, in the opinion of the Investigator, would place the neonate at undue risk
Participation in another clinical trial of any placebo, drug or biological substance conducted under the provisions of a protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Speer, MD
Organizational Affiliation
Universitäts-Kinderklinik Würzburg (Germany)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Liverpool Women's Hospital Neonatal Unit Liverpool Women's Hospital
City
Liverpool
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28465315
Citation
Sweet DG, Turner MA, Stranak Z, Plavka R, Clarke P, Stenson BJ, Singer D, Goelz R, Fabbri L, Varoli G, Piccinno A, Santoro D, Speer CP. A first-in-human clinical study of a new SP-B and SP-C enriched synthetic surfactant (CHF5633) in preterm babies with respiratory distress syndrome. Arch Dis Child Fetal Neonatal Ed. 2017 Nov;102(6):F497-F503. doi: 10.1136/archdischild-2017-312722. Epub 2017 May 2.
Results Reference
result
Links:
URL
https://www.clinicaltrialsregister.eu/ctr-search/search?query=2011-001331-22
Description
Study Record on EU Clinical Trials Register including results
Learn more about this trial
First In Human Study on Synthetic Surfactant CHF 5633 in Respiratory Distress Syndrome
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