deltatrials
Completed PHASE2 INTERVENTIONAL 4-arm NCT03712280

MNK6106 for Liver Disease (Hepatic Cirrhosis) That in the Past Has Affected the Brain (Hepatic Encephalopathy)

A Randomized, Open-Label, Phase 2a Comparator Study to Assess the Pharmacodynamics, Safety and Pharmacokinetics of Oral Administration MNK6106 (L-Ornithine Phenylacetate) Versus Rifaximin in Subjects With Hepatic Cirrhosis and a History of Prior Episodes of Hepatic Encephalopathy

Sponsor: Mallinckrodt

Updated 15 times since 2018 Last updated: Jun 29, 2021 Started: Dec 1, 2018 Primary completion: Jul 14, 2020 Completion: Jul 14, 2020
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03712280, this PHASE2 trial focuses on Hepatic Cirrhosis and Hepatic Encephalopathy (HE) and remains completed. Sponsored by Mallinckrodt, it has been updated 15 times since 2018, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Nov 2018 – ~Dec 2018 · 30 days · monthly snapshot~Dec 2018 – ~Jan 2019 · 31 days · monthly snapshot~Jan 2019 – ~Aug 2019 · 7 months · monthly snapshot~Aug 2019 – ~Sep 2019 · 31 days · monthly snapshot~Sep 2019 – ~Dec 2019 · 3 months · monthly snapshot~Dec 2019 – ~Jan 2020 · 31 days · monthly snapshot~Jan 2020 – ~Jun 2020 · 5 months · monthly snapshot~Jun 2020 – ~Jul 2020 · 30 days · monthly snapshot~Jul 2020 – ~Aug 2020 · 31 days · monthly snapshot~Aug 2020 – ~Jan 2021 · 5 months · monthly snapshot~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshot~Sep 2021 – ~Jul 2024 · 34 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 12 months · monthly snapshot

Change History

15 versions recorded
  1. Sep 2025 — Present [monthly]

    Completed PHASE2

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  4. Sep 2021 — Jul 2024 [monthly]

    Completed PHASE2

  5. Jan 2021 — Sep 2021 [monthly]

    Completed PHASE2

Show 10 earlier versions
  1. Aug 2020 — Jan 2021 [monthly]

    Completed PHASE2

    Status: RecruitingCompleted

  2. Jul 2020 — Aug 2020 [monthly]

    Recruiting PHASE2

  3. Jun 2020 — Jul 2020 [monthly]

    Recruiting PHASE2

  4. Jan 2020 — Jun 2020 [monthly]

    Recruiting PHASE2

  5. Dec 2019 — Jan 2020 [monthly]

    Recruiting PHASE2

  6. Sep 2019 — Dec 2019 [monthly]

    Recruiting PHASE2

  7. Aug 2019 — Sep 2019 [monthly]

    Recruiting PHASE2

  8. Jan 2019 — Aug 2019 [monthly]

    Recruiting PHASE2

    Status: Not Yet RecruitingRecruiting

  9. Dec 2018 — Jan 2019 [monthly]

    Not Yet Recruiting PHASE2

  10. Nov 2018 — Dec 2018 [monthly]

    Not Yet Recruiting PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Mallinckrodt
Data source: Mallinckrodt

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