Use of Oxandrolone to Promote Growth in Infants With HLHS (NCT04090697) | Clinical Trial Compass
TerminatedPhase 1/2
Use of Oxandrolone to Promote Growth in Infants With HLHS
Stopped: FDA withdrawal of Oxandrin NDA and generic ANDAs
United States34 participantsStarted 2019-12-20
Plain-language summary
The primary aim of this study is to determine if clinically relevant doses of buccally administered oxandrolone are safe and tolerable in neonates with hypoplastic left heart syndrome (HLHS) or other single right ventricular anomalies who have undergone a Norwood procedure. The secondary aim is to evaluate the efficacy of buccally administered oxandrolone in improving objective indices of growth and nutrition in neonates who have undergone a Norwood procedure.
Who can participate
Age range14 Days
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. HLHS and other single ventricle of right ventricular morphology
✓. Age and Norwood procedure ≤14 days of age
✓. Informed consent from parent/guardian
Exclusion criteria
✕. Small for gestational age (birth weight \<10th percentile for gestational age)
✕. Prematurity, defined as gestational age \<37 weeks
✕. Intrauterine growth retardation (birth weight ≤2.5 kg and gestational age ≥38 weeks)
✕. Chromosomal abnormality, recognizable genetic syndrome or congenital anomalies of more than minor severity associated with growth failure
✕. Moderate or greater right ventricular systolic dysfunction and/or moderate or greater tricuspid regurgitation prior to the Norwood procedure
✕. Extracorporeal membrane oxygenation support (ECMO) prior to or within 24 hours of Norwood procedure
What they're measuring
1
Biochemical evidence of hepatic dysfunction
Timeframe: From date of treatment initiation until the pre-SCPC evaluation or end of study participation, whichever comes first, up to 9 months
2
Virilization
Timeframe: From date of treatment initiation until the completion of study drug therapy or end of study participation, whichever comes first, up to 28 days
3
SAE probably or definitely related to oxandrolone therapy
Timeframe: From date of treatment initiation until the pre-SCPC evaluation or end of study participation, whichever comes first, up to 9 months