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NCT04090697 · ClinicalTrials.gov registry record · Phase 1
Use of Oxandrolone to Promote Growth in Infants With HLHS
A Phase 1 study, sponsored by Carelon Research.
- Terminated
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
NCT04090697: Clinical Trial Phase 1 study, sponsored by Carelon Research.
NCT04090697 is a Phase 1 study that was terminated before completion, run by Carelon Research. The registered enrollment target is 34 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04090697, a Phase 1 study, was terminated before completion, sponsored by Carelon Research.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
Study 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.
Primary Outcome
Elevation of serum transaminase levels (alanine transaminase (ALT) and/or aspartate transaminase (AST)) \>4 times the local laboratory upper limit of normal
Interventions
- DRUG Oxandrolone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2019-12-20 |
| Est. Completion | 2023-09-19 |
| Phase | Phase 1 |
Why NCT04090697 stopped before completion
NCT04090697 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 1 intervention - of which Oxandrolone is the first listed.
NCT04090697 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04090697 about?
NCT04090697 is a clinical study titled "Use of Oxandrolone to Promote Growth in Infants With HLHS". 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 e...
What is the current status of trial NCT04090697?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2019-12-20. Estimated completion is 2023-09-19.
What interventions are being tested in trial NCT04090697?
The interventions under investigation include: Oxandrolone (DRUG).
Who is sponsoring clinical trial NCT04090697?
This trial is sponsored by Carelon Research, which has 50 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04090697's enrollment target sits among peer trials
34 1273rd of 2000 higher than 721 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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