Safety and Efficacy of APC-0101 in Preterm Infants With Respiratory Distress Syndrome

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Aerogen Pharma Limited
Study ID
NCT06776783
Phase
PHASE3
Status
Recruiting
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Conditions

  • Pre-term Infants
  • Respiratory Distress Syndrome

Eligibility Criteria

Sex
ALL
Age
1 Hour - 24 Hours
Healthy Volunteers
Not accepted

Interventions

  • APC-0101 (SF-RI 1 surfactant for inhalation combined with a dedicated delivery system) — COMBINATION_PRODUCT
    Subjects in the APC-0101 group will be changed from their current nCPAP/NIV interface to the APC-0101 nCPAP/NIV interface and APC-0101 treatment will be started.
  • Control — OTHER
    Subjects in the Control group will be changed from their current nCPAP/NIV interface to the APC-0101 nCPAP/NIV interface but an empty vial will be used instead of APC-0101.

Study Details

This is a 2-part, prospective, randomized, blinded, sham-controlled, multi-center study comparing preterm subjects with RDS who are treated with APC-0101 and nCPAP/NIV to subjects treated with nCPAP/NIV alone (Sham). In Part 1, subjects will be followed until they reach 40 weeks post-menstrual age (PMA) or are discharged from the NICU, whichever comes first. In Part 2, subjects will undergo post-term follow-up through 24 months corrected age.

Key Dates

Start date
Sep 24, 2025
Status verified
Apr 2026
Primary completion
May 31, 2027
Completion
May 31, 2029

Study Design

Enrollment
520 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Sham Comparator: Control Group
  • Experimental: APC-0101 Group

Primary Outcome Measure

Failure Criteria [ Time Frame: First 7 days of life ]

Central Contacts

Locations (12)

FacilityCityStateZIPSite coordinators
University of Arkansas for Medical SciencesLittle RockArkansas72205
Vonita Chawla, MD
[email protected]
631-682-0812
Jacobs Medical CenterLa JollaCalifornia92037
Sarah Lazar, MPH
[email protected]
858-249-1711
UF Health JacksonvilleJacksonvilleFlorida32209
Megan Mathews
[email protected]
904-244-5450
Advent HealthOrlandoFlorida32803
Narendra Dereddy, MD
[email protected]
407-609-3280
Memorial Hospital of South BendSouth BendIndiana46601
Amber Wallace
[email protected]
574-647-3048
Goryeb Children's HospitalMorristownNew Jersey07960
John Ladino, MD
[email protected]
973-971-5488
The Trustees of Columbia University in the City of New YorkNew YorkNew York10032
Rakesh Sahni, MD
[email protected]
212-305-8500
Montefiore Medical CenterThe BronxNew York10461
Ibadete Xama, MBA
[email protected]
Maria Farreri Children's HospitalValhallaNew York10595
Edmund F LaGamma, MD
[email protected]
914-493-8558
Christus Children's HospitalSan AntonioTexas78207
Terri Newsom
[email protected]
210-704-2823
University of Virginia School of MedicineCharlottesvilleVirginia22903
Heeju Snyder, CCRP
[email protected]
WVU Medicine Children's HospitalMorgantownWest Virginia26506
Mark Polak
[email protected]
304-293-1202

Find similar trials in Little Rock, AR

By research site
University of Arkansas for Medical Sciences· Little Rock, ARJacobs Medical Center· La Jolla, CAUF Health Jacksonville· Jacksonville, FLAdvent Health· Orlando, FLMemorial Hospital of South Bend· South Bend, INGoryeb Children's Hospital· Morristown, NJ

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