Pharmacokinetics and Safety Profile of Digoxin in Infants With Single Ventricle Congenital Heart Disease (DGX01)
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ClinicalTrials.gov Identifier: NCT03877965 |
Recruitment Status :
Enrolling by invitation
First Posted : March 18, 2019
Last Update Posted : March 12, 2021
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Tracking Information | |||||
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First Submitted Date | March 14, 2019 | ||||
First Posted Date | March 18, 2019 | ||||
Last Update Posted Date | March 12, 2021 | ||||
Actual Study Start Date | August 5, 2019 | ||||
Estimated Primary Completion Date | July 1, 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
Plasma concentrations of digoxin [ Time Frame: Approximately 7 months ] The primary outcome measures are plasma concentrations of digoxin measured using a validated bioanalytical assay at a central laboratory.
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Original Primary Outcome Measures |
Plasma concentrations of dixogin [ Time Frame: Approximately 7 months ] | ||||
Change History | |||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures |
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Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Same as current | ||||
Descriptive Information | |||||
Brief Title | Pharmacokinetics and Safety Profile of Digoxin in Infants With Single Ventricle Congenital Heart Disease | ||||
Official Title | Pharmacokinetics and Safety Profile of Digoxin in Infants With Single Ventricle Congenital Heart Disease | ||||
Brief Summary | This is a prospective, multi-center, open-label, PK and safety profile study of enteral digoxin in children <6 months old at time of enrollment, post-surgical or hybrid stage 1 palliation, but prior to surgical stage 2 palliation. | ||||
Detailed Description | The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) funded this protocol titled "Pharmacokinetics and Safety Profile of Digoxin in Infants with Single Ventricle Congenital Heart Disease", protocol number NICHD-2018-DGX01. The Investigational New Drug (IND) Sponsor and Principal Investigator for this protocol is Christopher P. Hornik, MD, MPH. The Contracting Officer's Technical Representative (COTR) to represent the Government for this task order is Perdita Taylor-Zapata. The Duke IRB number for this study is Pro00102130. This study employs a central IRB, the WIRB-Copernicus Group (WCG). The c-IRB (WCG) study number is 20190888 / NICHD-2018-DGX01. This is a prospective, multicenter Phase 1 study with a primary objective to characterize the pharmacokinetics of enteral digoxin in infants with single ventricle congenital heart disease. The secondary objective is to determine the safety profile of enteral digoxin in infants with single ventricle congenital heart disease. Digoxin is used for the treatment of heart failure in pediatric patients and acts by controlling numerous functions of the cardiovascular system. Digoxin use in single ventricle congenital heart disease may decrease interstage mortality. The study will be conducted in approximately 48 subjects at approximately 13 investigational centers. The proposed duration of the study is approximately 196 (±) days. Please see the protocol and synopsis for more information. |
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Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Retention: Samples Without DNA Description: Blood samples will be collected to assess pharmacokinetic and biomarker levels
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Sampling Method | Probability Sample | ||||
Study Population | Up to 48 infants diagnosed with single ventricle congenital heart disease, receiving digoxin per standard of care during the interstage period | ||||
Condition | Congenital Heart Disease | ||||
Intervention | Drug: Digoxin
Drug administered per standard of care, with a dosing regimen within the labeled dose range of 7.5-20 mcg/kg/day divided in 2 or 3 equal doses
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Study Groups/Cohorts | Children with single ventricle congenital heart disease
Receiving digoxin per standard of care during the interstage period
Intervention: Drug: Digoxin
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Enrolling by invitation | ||||
Estimated Enrollment |
48 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | December 1, 2022 | ||||
Estimated Primary Completion Date | July 1, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | up to 6 Months (Child) | ||||
Accepts Healthy Volunteers | Not Provided | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03877965 | ||||
Other Study ID Numbers | Pro00102130 NICHD-2018-DGX01 ( Other Identifier: Duke ) HHSN27500002 ( Other Grant/Funding Number: NICHD ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Christoph P Hornik, MD MPH, Duke University | ||||
Study Sponsor | Christoph P Hornik, MD MPH | ||||
Collaborators |
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Investigators |
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PRS Account | Duke University | ||||
Verification Date | March 2021 |