deltatrials
Completed PHASE2 INTERVENTIONAL 1-arm NCT02117713

An Extension Study to Evaluate the Long-Term Safety and Durability of Effect of LUM001 in the Treatment of Cholestatic Liver Disease in Pediatric Subjects With Alagille Syndrome (IMAGINE-II)

A Multicenter Extension Study to Evaluate the Long-Term Safety and Durability of the Therapeutic Effect of LUM001, an Apical Sodium-Dependent Bile Acid Transporter Inhibitor (ASBTi), in the Treatment of Cholestatic Liver Disease in Pediatric Subjects With Alagille Syndrome

Sponsor: Childhood Liver Disease Research and Education Network

Updated 16 times since 2017 Last updated: Jun 29, 2021 Started: Mar 16, 2015 Primary completion: Jun 1, 2020 Completion: Jun 1, 2020
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE2 clinical study on Alagille Syndrome, this trial is completed. The trial is conducted by Childhood Liver Disease Research and Education Network and has accumulated 16 data snapshots since 2015. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~May 2017 · 3 months · monthly snapshot~May 2017 – ~Jun 2018 · 13 months · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Aug 2018 · 31 days · monthly snapshot~Aug 2018 – ~Sep 2018 · 31 days · monthly snapshot~Sep 2018 – ~Dec 2018 · 3 months · monthly snapshot~Dec 2018 – ~Apr 2019 · 4 months · monthly snapshot~Apr 2019 – ~Dec 2019 · 8 months · monthly snapshot~Dec 2019 – ~Jul 2020 · 7 months · monthly snapshot~Jul 2020 – ~Jan 2021 · 6 months · monthly snapshot~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshot~Sep 2021 – ~Dec 2021 · 3 months · monthly snapshot~Dec 2021 – ~Jul 2024 · 31 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – present · 24 months · monthly snapshot

Change History

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

    Completed PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  3. Dec 2021 — Jul 2024 [monthly]

    Completed PHASE2

  4. Sep 2021 — Dec 2021 [monthly]

    Completed PHASE2

  5. Jan 2021 — Sep 2021 [monthly]

    Completed PHASE2

Show 11 earlier versions
  1. Jul 2020 — Jan 2021 [monthly]

    Completed PHASE2

    Status: Active Not RecruitingCompleted

  2. Dec 2019 — Jul 2020 [monthly]

    Active Not Recruiting PHASE2

  3. Apr 2019 — Dec 2019 [monthly]

    Active Not Recruiting PHASE2

  4. Dec 2018 — Apr 2019 [monthly]

    Active Not Recruiting PHASE2

  5. Sep 2018 — Dec 2018 [monthly]

    Active Not Recruiting PHASE2

  6. Aug 2018 — Sep 2018 [monthly]

    Active Not Recruiting PHASE2

  7. Jul 2018 — Aug 2018 [monthly]

    Active Not Recruiting PHASE2

  8. Jun 2018 — Jul 2018 [monthly]

    Active Not Recruiting PHASE2

  9. May 2017 — Jun 2018 [monthly]

    Active Not Recruiting PHASE2

  10. Feb 2017 — May 2017 [monthly]

    Active Not Recruiting PHASE2

    Status: RecruitingActive Not Recruiting

  11. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE2

    First recorded

Mar 2015

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Childhood Liver Disease Research and Education Network
  • Lumena Pharmaceuticals, Inc.
  • Mirum Pharmaceuticals, Inc.
Data source: Mirum Pharmaceuticals, Inc.

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