deltatrials
Completed PHASE3 INTERVENTIONAL 1-arm NCT01115582

Efficacy of To Be Marketed (TBM) Cholic Acid Capsules Used to Treat Children With Inborn Errors of Bile Acid Synthesis

Open Label, Single Center, Nonrandomized Study Comparing Efficacy of To Be Marketed Cholic Acid With That of the Currently Used Formulation of Cholic Acid Capsules Used to Treat Children With Inborn Errors of Bile Acid Synthesis

Sponsor: Mirum Pharmaceuticals, Inc.

Interventions Cholic acid
Updated 10 times since 2017 Last updated: Sep 29, 2023 Started: Apr 30, 2010 Primary completion: Aug 31, 2010 Completion: Aug 31, 2010
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01115582, this PHASE3 trial focuses on Inborn Errors of Bile Acid Synthesis and remains completed. Sponsored by Mirum Pharmaceuticals, Inc., it has been updated 10 times since 2010, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotCompleted~Jun 2018 – ~Oct 2018 · 4 months · monthly snapshotCompleted~Oct 2018 – ~Jan 2021 · 27 months · monthly snapshotCompleted~Jan 2021 – ~Dec 2022 · 23 months · monthly snapshotCompleted~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshotCompleted~Jan 2023 – ~Nov 2023 · 10 months · monthly snapshotCompleted~Nov 2023 – ~Jul 2024 · 8 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 22 months · monthly snapshotCompleted

Change History

10 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed PHASE3

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  3. Nov 2023 — Jul 2024 [monthly]

    Completed PHASE3

  4. Jan 2023 — Nov 2023 [monthly]

    Completed PHASE3

  5. Dec 2022 — Jan 2023 [monthly]

    Completed PHASE3

Show 5 earlier versions
  1. Jan 2021 — Dec 2022 [monthly]

    Completed PHASE3

  2. Oct 2018 — Jan 2021 [monthly]

    Completed PHASE3

  3. Jun 2018 — Oct 2018 [monthly]

    Completed PHASE3

  4. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE3

  5. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE3

    First recorded

Apr 2010

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Mirum Pharmaceuticals, Inc.
Data source: Mirum Pharmaceuticals, Inc.

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

Study Locations