Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ST266 in Infants With Necro… (NCT06315738) | Clinical Trial Compass
RecruitingPhase 1/2
Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ST266 in Infants With Necrotizing Enterocolitis (NEC)
United States36 participantsStarted 2024-08-19
Plain-language summary
The primary objective of this study is to determine the safety and tolerability of two dose levels (0.5 mL/kg and 1.0 mL/kg) of once daily (QD) via IV route of administration of ST266 in treating patients with Bell's stage IIA or higher medical NEC by incidence of treatment emergent adverse events (TEAEs) and SAEs, with a secondary objective to assess preliminary efficacy of the same two dose levels (0.5 mL/kg and 1.0 mL/kg) of QD via IV route of administration of ST266 in treating patients with Bell's stage IIA or higher medical NEC.
Who can participate
Age range2 Weeks – 8 Weeks
SexALL
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Inclusion criteria
✓. Infants born from ≥22 weeks gestational age up to and including 40 weeks gestational age; up to 40 weeks postmenstrual age (gestational age plus chronological age in terms of weeks) with current weight at diagnosis of NEC between ≥500g and ≤3000g, as a result of prematurity and/or IUGR. Parent(s)/legal medical representative(s) voluntarily provides written consent prior to study enrollment.
✓. Bell's Stage IIA or higher medical NEC (Stages IIA - IIIA only) diagnosis by radiologic confirmed pneumatosis intestinalis and may include intestinal dilation and ileus. The clinician confirms NEC diagnosis by evaluation of the radiologic imaging for confirmed pneumatosis intestinalis. If X-ray is used and is equivocal, an ultrasound (US) may be used, if available, to confirm pneumatosis. If the clinician (Neonatologist and/or Pediatric Surgeon) has differing interpretation from that of the Radiologist, that should be documented in both the medical and research records for accuracy of NEC diagnosis.
Exclusion criteria
✕. Infants with abdominal perforation.
✕. Not expected to survive ≥2 weeks or born with a lethal condition requiring hospice or palliative care (e.g., disease has progressed to NEC totalis, or patient has multi-organ system failure).
✕. Born with major congenital anomalies such as cardiac defects (e.g., Tetralogy of Fallot) or chromosomal disorders/anomalies (e.g., neural tube defect).
What they're measuring
1
Safety and Tolerability endpoint: incidence of adverse events
Timeframe: From date of randomization through 24 months of age
2
Safety and Tolerability endpoint: incidence of serious adverse events
Timeframe: From date of randomization through 24 months of age
3
Safety and Tolerability endpoint: Changes in labs and vitals relative to disease progression
Timeframe: From date of randomization through 24 months of age
✕. Mother's receipt of any investigational product during pregnancy.
✕. Infants with malignancies (e.g., neoplastic cell growth as a solid tumor or a blood neoplasm, such as congenital leukemia).
✕. Infants with hypercoagulability disorders (any active thrombosis, diagnosis of disseminated intravascular coagulation or other acquired/inherited disorders (i.e., hemophilia) of coagulation.
✕. Infants with a known immunodeficiency (such as galactosemia or agranulocytosis).
✕. Infants with anatomic defects that require surgical intervention.