deltatrials
Completed PHASE2 INTERVENTIONAL 3-arm NCT03112681

Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Mg in Patients With Primary Biliary Cholangitis (EPICS)

A Phase 2, Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Magnesium in Patients With Primary Biliary Cholangitis (EPICS )

Sponsor: Zydus Therapeutics Inc.

Conditions Primary Biliary Cirrhosis
Interventions Placebo Oral Tablet Saroglitazar magnesium 2 mg Saroglitazar magnesium 4 mg
Updated 22 times since 2017 Last updated: Sep 3, 2024 Started: Aug 18, 2017 Primary completion: Aug 7, 2020 Completion: Aug 7, 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 Primary Biliary Cirrhosis, this trial is completed. The trial is conducted by Zydus Therapeutics Inc. and has accumulated 22 data snapshots since 2017. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~May 2017 – ~Feb 2018 · 9 months · monthly snapshot~Feb 2018 – ~May 2018 · 3 months · monthly snapshot~May 2018 – ~Jun 2018 · 31 days · 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 – ~Oct 2018 · 30 days · monthly snapshot~Oct 2018 – ~Feb 2019 · 4 months · monthly snapshot~Feb 2019 – ~Aug 2019 · 6 months · monthly snapshot~Aug 2019 – ~Dec 2019 · 4 months · monthly snapshot~Dec 2019 – ~May 2020 · 5 months · monthly snapshot~May 2020 – ~Jun 2020 · 31 days · monthly snapshot~Jun 2020 – ~Jul 2020 · 30 days · monthly snapshot~Jul 2020 – ~Oct 2020 · 3 months · monthly snapshot~Oct 2020 – ~Jan 2021 · 3 months · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Oct 2021 · 8 months · monthly snapshot~Oct 2021 – ~Feb 2024 · 28 months · monthly snapshot~Feb 2024 – ~Jul 2024 · 5 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Oct 2024 · 30 days · monthly snapshot~Oct 2024 – present · 21 months · monthly snapshot

Change History

22 versions recorded

  1. Oct 2024 — Present [monthly]

    Completed PHASE2

  2. Sep 2024 — Oct 2024 [monthly]

    Completed PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  4. Feb 2024 — Jul 2024 [monthly]

    Completed PHASE2

  5. Oct 2021 — Feb 2024 [monthly]

    Completed PHASE2

▶ Show 17 earlier versions

  1. Feb 2021 — Oct 2021 [monthly]

    Completed PHASE2

    Status: Active Not Recruiting → Completed

  2. Jan 2021 — Feb 2021 [monthly]

    Active Not Recruiting PHASE2

  3. Oct 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE2

  4. Jul 2020 — Oct 2020 [monthly]

    Active Not Recruiting PHASE2

  5. Jun 2020 — Jul 2020 [monthly]

    Active Not Recruiting PHASE2

  6. May 2020 — Jun 2020 [monthly]

    Active Not Recruiting PHASE2

    Status: Recruiting → Active Not Recruiting

  7. Dec 2019 — May 2020 [monthly]

    Recruiting PHASE2

  8. Aug 2019 — Dec 2019 [monthly]

    Recruiting PHASE2

  9. Feb 2019 — Aug 2019 [monthly]

    Recruiting PHASE2

  10. Oct 2018 — Feb 2019 [monthly]

    Recruiting PHASE2

  11. Sep 2018 — Oct 2018 [monthly]

    Recruiting PHASE2

  12. Aug 2018 — Sep 2018 [monthly]

    Recruiting PHASE2

  13. Jul 2018 — Aug 2018 [monthly]

    Recruiting PHASE2

  14. Jun 2018 — Jul 2018 [monthly]

    Recruiting PHASE2

  15. May 2018 — Jun 2018 [monthly]

    Recruiting PHASE2

  16. Feb 2018 — May 2018 [monthly]

    Recruiting PHASE2

    Status: Not Yet Recruiting → Recruiting

  17. May 2017 — Feb 2018 [monthly]

    Not Yet Recruiting PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Zydus Therapeutics Inc.
Data source: Zydus Therapeutics Inc.

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

Study Locations