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

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11110%2F17%3A10366172" target="_blank" >RIV/00216208:11110/17:10366172 - isvavai.cz</a>

Alternative codes found

RIV/00023698:_____/17:N0000026 RIV/00064165:_____/17:10366172

Result on the web

<a href="http://dx.doi.org/10.1136/archdischild-2017-312722" target="_blank" >http://dx.doi.org/10.1136/archdischild-2017-312722</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1136/archdischild-2017-312722" target="_blank" >10.1136/archdischild-2017-312722</a>

Result language

angličtina

Original language name

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

Original language description

Objective CHF5633 (Chiesi Farmaceutici S.p.A., Parma, Italy) is the first fully synthetic surfactant enriched by peptide analogues of two human surfactant proteins. We planned to assess safety and tolerability of CHF5633 and explore preliminary efficacy. Design Multicentre cohort study. Patients Forty infants from 27(0+) to 33(+6) weeks gestation with respiratory distress syndrome requiring fraction of inspired oxygen (FiO(2))&gt;= 0.35 were treated with a single dose of CHF5633 within 48 hours after birth. The first 20 received 100 mg/kg and the second 20 received 200 mg/kg. Outcome measures Adverse events (AEs) and adverse drug reactions (ADRs) were monitored with complications of prematurity considered AEs if occurring after dosing. Systemic absorption and immunogenicity were assessed. Efficacy was assessed by change in FiO(2) after dosing and need for poractant-alfa rescue. Results Rapid and sustained improvements in FiO(2) were observed in 39 (98%) infants. One responded neither to CHF5633 nor two poractant-alfa doses. A total of 79 AEs were experienced by 19 infants in the 100 mg/kg cohort and 53 AEs by 20 infants in the 200 mg/kg cohort. Most AEs were expected complications of prematurity. Two unrelated serious AEs occurred in the second cohort. One infant died of necrotising enterocolitis and another developed viral bronchiolitis after discharge. The single ADR was an episode of transient endotracheal tube obstruction following a 200 mg/kg dose. Neither systemic absorption, nor antibody development to either peptide was detected. Conclusions Both CHF5633 doses were well tolerated and showed promising clinical efficacy profile. These encouraging data provide a basis for ongoing randomised controlled trials.

Czech name

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Czech description

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Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

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OECD FORD branch

30209 - Paediatrics

Project

—

Continuities

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Publication year

2017

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

Archives of Disease in Childhood: Fetal and Neonatal Edition

ISSN

1359-2998

e-ISSN

—

Volume of the periodical

102

Issue of the periodical within the volume

6

Country of publishing house

GB - UNITED KINGDOM

Number of pages

7

Pages from-to

"F497"-"F503"

UT code for WoS article

000416083000007

EID of the result in the Scopus database

2-s2.0-85032027527