RECRUITING

IMProving DRug Dosing and Outcomes for Single VEntricle Patients With Fontan Associated Liver Disease

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Conditions

Fontan CirculationFontanFALD

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a single center, open-label, prospective, investigation to quantify the effects liver congestion and fibrosis has on hepatic drug metabolism and transport in children, adolescents, and young adults with Fontan circulation.

Official Title

IMProving DRug Dosing and Outcomes for Single VEntricle Patients With Fontan Associated Liver Disease

Quick Facts

Study Start:2024-03-01
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06324396

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:8 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * \> 8 years
  2. * Status Post Fontan Completion
  3. * Ability to provide informed permission-assent (\<18 years) or consent (≥18 years)
  4. * Fasting overnight (\~8 hours)
  1. * Pregnancy
  2. * Non-fasting
  3. * Non-removable metal in body or where magnetic resonance imaging (MRI) is considered unsafe
  4. * Sildenafil and/or Pravastatin therapy within last 2 months
  5. * History of underlying or laboratory evidence of underlying intestinal, metabolic, autoimmune, renal disease that can alter Sildenafil and Pravastatin disposition (absorption, metabolism, distribution, or clearance)
  6. * Pharmacotherapy that interacts with Sildenafil (cytochrome P450 3A4 and P450 3A5 (CYP3A4/5) inducers/inhibitors) and/or Pravastatin (organic anion transporting polypeptide (OATP1B1) inducers/inhibitors)
  7. * Inability to swallow a tablet
  8. * \>5X the age-specific upper limit of normal for aspartate aminotransferase (AST) and alanine aminotransferase (ALT), total and conjugated bilirubin
  9. * Diarrhea in the last 24 hours

Contacts and Locations

Study Contact

Jonthan Wagner, DO
CONTACT
816-731-7240
jbwagner@cmh.edu

Principal Investigator

Jonathan Wagner, DO
PRINCIPAL_INVESTIGATOR
Children's Mercy

Study Locations (Sites)

Children's Mercy Hospital
Kansas City, Missouri, 64108
United States

Collaborators and Investigators

Sponsor: Children's Mercy Hospital Kansas City

  • Jonathan Wagner, DO, PRINCIPAL_INVESTIGATOR, Children's Mercy

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-01
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2024-03-01
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • Fontan
  • FALD

Additional Relevant MeSH Terms

  • Fontan Circulation