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Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis

StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Enrollment reduced: 150 → 102 participants
    • Trial status changed: Recruiting → Active, Not Recruiting
    • Site details revised at 28 of 28 sites
    v8
  2. Study sites: 41 to 28v7
  3. Site details revised at 6 of 41 sitesv6
  4. Site details revised at 5 of 41 sitesv5
  5. Study sites: 45 to 41
    • Eligibility criteria shortened, about 2 words
    v4
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  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 47 to 45
    • Start date changed from estimate of Jun 15, 2024 to Jul 16, 2024
    • Eligibility criteria expanded, about 6 words
    v3
  2. Start date: May 15, 2024 to Jun 15, 2024
    • Secondary endpoints: details revised at 3 of 21 entries
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis
Trial Details
NCT Number NCT06427395
Lead Sponsor Zydus Therapeutics Inc.
Conditions
(from sponsor)		 Primary Biliary Cholangitis
Related terms Liver Cirrhosis, Biliary
Enrollment 102 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov