MedTrace Logo

Use of Oxandrolone to Promote Growth in Infants With HLHS

NCT04090697 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2024-05-23

No results posted yet for this 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.

Conditions

  • Hypoplastic Left Heart
  • Congenital Heart Disease

Interventions

DRUG

Oxandrolone

Oxandrolone 2.5mg tabs will be suspended in multi-chain triglyceride (MCT) oil and administered buccally.

Sponsors & Collaborators

  • Carelon Research

    lead OTHER

Principal Investigators

  • Phillip T Burch, MD · University of Mississippi Medical Center

  • Richard V Williams, MD · University of Utah

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
14 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-20
Primary Completion
2023-09-19
Completion
2023-09-19
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04090697 on ClinicalTrials.gov