First In Human Study on Synthetic Surfactant CHF 5633 in Respiratory Distress Syndrome

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Chiesi Farmaceutici S.p.A.
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:
NCT01651637
First received: April 20, 2012
Last updated: January 30, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Respiratory Distress Syndrome in Premature Infants
Drug: synthetic surfactant (CHF5633)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Chiesi Farmaceutici S.p.A.:

Primary Outcome Measures:
  • Monitoring of adverse events following CHF5633 administration [ Time Frame: For duration of hospital stay (expected average of 9 weeks) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: October 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Synthetic Surfactant
Cohort Design
Drug: synthetic surfactant (CHF5633)
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

Detailed Description:

The study will be a multicentre, open-label, single escalating dose, per-cohort design.

  Eligibility

Ages Eligible for Study:   27 Weeks to 34 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01651637

Contacts
Contact: Guido Varoli +390521279718 g.varoli@chiesi.com

Locations
United Kingdom
Liverpool Women's Hospital Neonatal Unit Liverpool Women's Hospital Recruiting
Liverpool, United Kingdom
Contact: Mark Turner, MD    (0) 151-702-4101 ext +44    mark.turner@liverpool.ac.uk   
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Investigators
Principal Investigator: Christian Speer, MD Universitäts-Kinderklinik Würzburg (Germany)
  More Information

No publications provided

Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT01651637     History of Changes
Other Study ID Numbers: CCD-1011-PR-0059
Study First Received: April 20, 2012
Last Updated: January 30, 2013
Health Authority: Germany: Ethics Commission
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Chiesi Farmaceutici S.p.A.:
Respiratory Distress syndrome
Complications of prematurity

Additional relevant MeSH terms:
Syndrome
Respiratory Distress Syndrome, Newborn
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Pulmonary Surfactants
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014