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Safety and Effectiveness of Sulfasalazine in the Treatment of Liver Fibrosis/Cirrhosis.

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Primary endpoints: 6 to 7v5 Show 6 more changesShow less
    • Interventions: Sulfasalazine enteric-coated tablets (Drug) to Sulfasalazine enteric-coated tablets (Drug), Sulfasalazine enteric-coated tablets (Drug), Sulfasalazine enteric-coated tablets (Drug)…
    • Eligibility criteria expanded, about 35 words
    • Secondary endpoint revised
    • Study description expanded, about 18 words
    • Site contacts updated at 1 of 2 sites
    • Publications: details revised at 3 of 3 entries
  2. Publications: details revised at 3 of 3 entriesv4
  3. Study completion date: Nov 10, 2028 to Oct 10, 2028
    • Start date: Feb 28, 2024 to Feb 1, 2024
    v3
  4. Re-verified, no change to tracked fieldsv2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a controlled, observational clinical study initiated by investigators to investigate the efficacy and safety of sulfasalazine in the treatment of cirrhosis in patients with cirrhosis. Four cohorts were planned: primary biliary cirrhosis, hepatitis B and C cirrhosis, and alcoholic cirrhosis. The four groups were divided into experimental group and control group, and the experimental group: each group of patients was orally treated sulfasalazine for 12 months, taken three times a day, each time taking 0.5g. The control group did not take sulfasalazine. After 12 months, Observe changes in patients' biochemical and imaging indicators, liver stiffness values, fecal microbiota, and metabolites before and after the use of sulfasalazine.
Trial Details
NCT Number NCT06293378
Lead Sponsor The Second Affiliated Hospital of Chongqing Medical University
Conditions
(from sponsor)		 Cirrhosis, Liver, Fibrosis, Liver
Related terms Liver Cirrhosis
Enrollment 330 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov