TerminatedPhase 1/2

Use of Oxandrolone to Promote Growth in Infants With HLHS

Stopped: FDA withdrawal of Oxandrin NDA and generic ANDAs

United States, Canada34 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 range

14 Days

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

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

Trial details

NCT IDNCT04090697

SponsorCarelon Research

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-19

View on ClinicalTrials.gov More Hypoplastic Left Heart trials

Plain-language summary

Who can participate

Age range

14 Days

Sex

ALL

See this in plain English?

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

What they're measuring

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

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

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