Efficacy and Safety Study of Ursodeoxycholic Acid to Treat Chronic Hepatitis C

StatusCompleted
PhasePhase 3
Started

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Record History

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  1. 2 versions Re-verified since Mar 7, 2012, no change to tracked fieldsv3-v4
  2. Phase: Not applicable to Phase 3v2 Show 7 more changesShow less
    • Results first posted: Nov 7, 2011
    • Primary endpoints: 1 to 2
    • Enrollment target: 600 to 596
    • Interventions: Ursodeoxycholic acid (Drug) to Ursodeoxycholic acid 150mg / day (Drug), Ursodeoxycholic acid 600mg / day (Drug), Ursodeoxycholic acid 900mg / day (Drug)
    • Secondary endpoints: 1 to 4
    • Publications: details revised at 1 of 1 entry
    • Study arms: 0 to 3
  3. Study First Submitted
  • 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.
This study is a 24-week multicenter, randomized, double-blind control trial with ursodeoxycholic acid (UDCA) in patients with chronic hepatitis C in Japan. The primary objectives of this study are to verify the superiority of efficacy of UDCA 600 or 900mg/day to that of 150mg/day and the safety of UDCA treatment.
Trial Details
NCT Number NCT00200343
Lead Sponsor Tanabe Pharma Corporation
Conditions
(from sponsor)		 Chronic Hepatitis C
Related terms Hepatitis C, Chronic
Enrollment 596 participants
Start Date
Study Completion (estimated)
Updated on ClinicalTrials.gov