Status:
TERMINATED
Use of Oxandrolone to Promote Growth in Infants With HLHS
Lead Sponsor:
Carelon Research
Conditions:
Hypoplastic Left Heart
Congenital Heart Disease
Eligibility:
All Genders
Up to 14 years
Phase:
PHASE1
PHASE2
Brief 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 ...
Detailed Description
The proposed investigation is a Phase I/II randomized trial of 28 days of open label oxandrolone vs. no oxandrolone treatment to assess optimal dosing, safety/tolerability, and preliminary efficacy of...
Eligibility Criteria
Inclusion
- HLHS and other single ventricle of right ventricular morphology
- Age and Norwood procedure ≤14 days of age
- Informed consent from parent/guardian
Exclusion
- 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
- Pre-Norwood interventions (fetal intervention, balloon atrial septostomy for an intact or restrictive atrial septum)
- Pre-Norwood pulmonary venous obstruction
- Pre-Norwood procedure necrotizing enterocolitis and/or other gastrointestinal syndromes
- Known contraindication to oxandrolone
- Planned or current warfarin therapy at screening (warfarin effects are increased by anabolic drugs)
- Significant hepatic dysfunction (elevation of serum transaminase levels greater than two times the upper limit of normal local laboratory standard at screening)
- Hypercalcemia (\>1.5 times upper normal range for lab)
- Nephrotic syndrome
- Unwillingness or inability to return to surgical center for follow-up evaluation
- Participation in another clinical study that may impact growth
Key Trial Info
Start Date :
December 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 19 2023
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04090697
Start Date
December 20 2019
End Date
September 19 2023
Last Update
May 23 2024
Active Locations (10)
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1
Children's Hospital of Atlanta
Atlanta, Georgia, United States, 30322
2
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
3
University of Michigan Health System, Ann Arbor
Ann Arbor, Michigan, United States, 48109
4
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229