NCT06613477View on ClinicalTrials.gov

PK/PD of Digoxin in Infants With SVHD

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

October 10, 2024

Primary Completion Date

September 30, 2026

Study Completion Date

October 31, 2026

Conditions
Single-ventricleInfant ConditionsInfant, Newborn, DiseasesInfant, Premature, Diseases
Interventions
DRUG

PK/PD Model Based Dosing of Digoxin in Infants with Single Ventricle Heart Disease

Table 3: Digoxin dosing regimen based on optimized Cmin,ss Dose to be given twice daily (mcg/kg/dose) PNA\<30 days 30 days \< PNA \< 180 days eGFR≤40 1.4 1.4 40\<eGFR≤60 1.6 1.6 eGFR\>60 1.9 2.8

Trial Locations (2)

27701

RECRUITING

Duke University Medical Center, Durham

29425

NOT_YET_RECRUITING

Medical University of South Carolina, Charleston

Sponsors

Lead Sponsor

Duke University
All Listed Sponsors
collaborator

Medical University of South Carolina

OTHER

collaborator

Duke Clinical Research Institute

OTHER

collaborator

National Center for Child Health and Development (NICHD)

UNKNOWN

collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

lead

Duke University

OTHER

NCT06613477 - PK/PD of Digoxin in Infants With SVHD | Biotech Hunter | Biotech Hunter