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Long-Term Study to Evaluate the Safety and Efficacy in Participants With Primary Biliary Cholangitis of Saroglitazar Magnesium-V on Clinical Outcomes

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

See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv4
  2. Recruitment opened
    • Trial sites expanded: 0 → 3 locations
    • Start date changed from estimate of Feb 2026 to Mar 24, 2026
    • Eligibility criteria expanded, about 6 words
    v3
  3. Start date: Dec 2025 to Feb 2026v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Long-Term Study to Evaluate the Safety and Efficacy in Participants with Primary Biliary Cholangitis of Saroglitazar Magnesium-V on Clinical Outcomes (EPICS-V)
Trial Details
NCT Number NCT07216235
Lead Sponsor Zydus Therapeutics Inc.
Conditions
(from sponsor)		 Primary Biliary Cholangitis
Related terms Liver Cirrhosis, Biliary
Enrollment 386 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov