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Study of Saroglitazar Magnesium for PBC Patients With Incomplete Response or Intolerant to UDCA Therapy

Study acronym: EPICS-IV
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Recruitment opened Show 6 more changesShow less
    • Enrollment target: 89 to 90
    • Study sites: 0 to 1
    • Start date changed from estimate of Jun 2026 to Aug 11, 2026
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 2 of 3 entries
    • Study description revised
  2. Start date: Mar 2026 to Jun 2026v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Study of Saroglitazar Magnesium for PBC Patients with Incomplete Response or Intolerant to UDCA Therapy
Trial Details
NCT Number NCT07424677
Lead Sponsor Zydus Therapeutics Inc.
Conditions
(from sponsor)		 Primary Biliary Cholangitis
Related terms Liver Cirrhosis, Biliary
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov