deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT03430583

Evaluation of Fontan-associated Hepatic Stiffness and the Efficacy of Udenafil in Reducing Liver Stiffness (FALD)

Imaging and Biomarker Evaluation of Hepatic Stiffness in Children Enrolled in the Fontan Udenafil Exercise Longitudinal Study

Sponsor: Mezzion Pharma Co. Ltd

Interventions Udenafil
Updated 19 times since 2018 Last updated: Sep 24, 2025 Started: Feb 20, 2018 Primary completion: Sep 15, 2020 Completion: Sep 16, 2020
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03430583, this PHASE3 trial focuses on Single Ventricle Heart Disease and remains completed. Sponsored by Mezzion Pharma Co. Ltd, it has been updated 19 times since 2018, reflecting substantial change activity. This study contributes longitudinal data to the cardiovascular research landscape.

Status Flow

~Mar 2018 – ~Apr 2018 · 31 days · monthly snapshot~Apr 2018 – ~May 2018 · 30 days · monthly snapshot~May 2018 – ~Jun 2018 · 31 days · monthly snapshot~Jun 2018 – ~Sep 2018 · 3 months · monthly snapshot~Sep 2018 – ~Oct 2018 · 30 days · monthly snapshot~Oct 2018 – ~Mar 2019 · 5 months · monthly snapshot~Mar 2019 – ~Feb 2020 · 11 months · monthly snapshot~Feb 2020 – ~Nov 2020 · 9 months · monthly snapshot~Nov 2020 – ~Dec 2020 · 30 days · monthly snapshot~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshot~Dec 2021 – ~Dec 2022 · 12 months · monthly snapshot~Dec 2022 – ~Jul 2024 · 19 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Jun 2025 · 9 months · monthly snapshot~Jun 2025 – ~Sep 2025 · 3 months · monthly snapshot~Sep 2025 – ~Oct 2025 · 30 days · monthly snapshot~Oct 2025 – ~Nov 2025 · 31 days · monthly snapshot~Nov 2025 – present · 8 months · monthly snapshot

Change History

19 versions recorded
  1. Nov 2025 — Present [monthly]

    Completed PHASE3

  2. Oct 2025 — Nov 2025 [monthly]

    Completed PHASE3

    Phase: NonePHASE3

  3. Sep 2025 — Oct 2025 [monthly]

    Completed

  4. Jun 2025 — Sep 2025 [monthly]

    Completed

    Status: UnknownCompleted

  5. Sep 2024 — Jun 2025 [monthly]

    Unknown

Show 14 earlier versions
  1. Jul 2024 — Sep 2024 [monthly]

    Unknown

    Status: Unknown StatusUnknown

  2. Dec 2022 — Jul 2024 [monthly]

    Unknown Status

    Status: Active Not RecruitingUnknown Status

  3. Dec 2021 — Dec 2022 [monthly]

    Active Not Recruiting

  4. Jan 2021 — Dec 2021 [monthly]

    Active Not Recruiting

  5. Dec 2020 — Jan 2021 [monthly]

    Active Not Recruiting

  6. Nov 2020 — Dec 2020 [monthly]

    Active Not Recruiting

  7. Feb 2020 — Nov 2020 [monthly]

    Active Not Recruiting

    Status: RecruitingActive Not Recruiting

  8. Mar 2019 — Feb 2020 [monthly]

    Recruiting

  9. Oct 2018 — Mar 2019 [monthly]

    Recruiting

  10. Sep 2018 — Oct 2018 [monthly]

    Recruiting

  11. Jun 2018 — Sep 2018 [monthly]

    Recruiting

  12. May 2018 — Jun 2018 [monthly]

    Recruiting

  13. Apr 2018 — May 2018 [monthly]

    Recruiting

    Phase: NANone

  14. Mar 2018 — Apr 2018 [monthly]

    Recruiting NA

    First recorded

Feb 2018

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Mezzion Pharma Co. Ltd
  • National Heart, Lung, and Blood Institute (NHLBI)
Data source: Mezzion Pharma Co. Ltd

For direct contact, visit the study record on ClinicalTrials.gov .