Respiratory Distress Syndrome in Premature InfantsPhase 1NCT01651637
First In Human Study on Synthetic Surfactant CHF 5633 in Respiratory Distress Syndrome
A Phase 1 study testing synthetic surfactant (CHF5633) in people with Respiratory Distress Syndrome in Premature Infants, run by Chiesi Farmaceutici S.p.A. at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 27 to 34 weeks
- Conditions the study is for
- Respiratory Distress Syndrome in Premature Infants
- What is being tested?
- synthetic surfactant (CHF5633)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2012to 23 Jan 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 27 to 34 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Liverpool Women's Hospital Neonatal Unit Liverpool Women's Hospital
Liverpool
About this study
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
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.
Read the detailed description
The study will be a multicentre, open-label, single escalating dose, per-cohort design.
- Being tested
- synthetic surfactant (CHF5633)
- Keywords
- Respiratory Distress syndrome, Complications of prematurity
- Medical subject headings
- Respiratory Distress Syndrome In Premature Infants, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
synthetic surfactant (CHF5633)Drug
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
| Study group | Role | What they receive |
|---|---|---|
| Synthetic Surfactant | Experimental | Cohort Design Receives: Drug: synthetic surfactant (CHF5633) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monitoring of adverse events following CHF5633 administration
Measured: For duration of hospital stay (expected average of 9 weeks)
Secondary outcomes (1)
CHF 5633 efficacy profile (oxygenation , ventilatory requirements and need for rescue surfactant treatment),systemic absorption and immunogenicity assesment
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2012 (estimated)
- Study startOct 2012
- Primary completion23 Jan 2015
- Study completion23 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress Syndrome in Premature InfantsStudies of the same condition, open and under way.
- More trials run by Chiesi Farmaceutici S.p.A.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christian Speer, MD, Principal investigator, Universitäts-Kinderklinik Würzburg (Germany)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01651637
- Sponsor's protocol ID
- CCD-1011-PR-0059
- Status last verified
- Jul 2020
- First submitted
- 20 Apr 2012
- Last updated
- 31 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 28465315
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01651637
- Acronym / sponsor ID
- CCD-1011-PR-0059
- Keywords
- Respiratory Distress syndrome, Complications of prematurity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- 23 Jan 2015 (actual)
- Study completion
- 23 Jan 2015 (actual)
- First posted
- 27 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Synthetic Surfactant | Experimental | Drug: synthetic surfactant (CHF5633)Cohort Design |
Who may qualify
- Ages
- 27 to 34 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | Synthetic Surfactant |
Primary outcome
Monitoring of adverse events following CHF5633 administration
Time frame: For duration of hospital stay (expected average of 9 weeks)
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2020.
- Results publication: PubMed 28465315Sweet 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.
- Study Record on EU Clinical Trials Register including resultsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Speer, MD principal investigator
Universitäts-Kinderklinik Würzburg (Germany)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing synthetic surfactant (CHF5633) in people with Respiratory Distress Syndrome in Premature Infants, run by Chiesi Farmaceutici S.p.A. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monitoring of adverse events following CHF5633 administration (time frame: For duration of hospital stay (expected average of 9 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01651637, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2020.