NCT06293378

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 330 (estimated)
• Sponsor: The Second Affiliated Hospital of Chongqing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This study is a controlled and observational clinical study initiated by the investigators to study the efficacy and safety of sulfasalazine in the treatment of cirrhosis in patients with cirrhosis, and to observe changes in patients' biochemical and imaging indicators, liver stiffness values, fecal microbiota, and metabolites before and after the use of sulfasalazine. Four cohorts were planned to be included in this study: Cohort A: Differences in cirrhosis changes with the addition of sulfasalazine to UDCA in PBC patients with an inadequate response to UDCA and treatment-naïve PBC patients. Cohort B: Differences in changes in cirrhosis in patients with viral hepatitis B cirrhosis compared with the addition of sulfasalazine to antiviral (if possible, the same antiviral) therapy. Cohort C: Differences in changes in cirrhosis in patients with viral hepatitis C cirrhosis compared with the addition of sulfasalazine to antiviral (if possible, the same antiviral) therapy. Cohort D: Differences in differences in changes in cirrhosis compared with sulfasalazine in patients with alcoholic hepatitis cirrhosis. Treatment options: 1. Patients with PBC who did not respond adequately to UDCA: 30 patients with poor response to treated PBC continued to take UDCA, 30 patients with poor response to treated PBC received UDCA+SASP (0.5 g orally three times daily), and 30 patients with poor response received SASP (0.5 g orally three times daily) for 12 months and were followed up for 12 months. Treatment-naïve PBC patients: 30 treatment-naïve PBC patients took UDCA, and 30 treatment-naïve PBC patients took UDCA+SASP (0.5 g orally three times a day) for 12 months and followed up for 12 months. 2. Treatment group of hepatitis B (hepatitis C) viral liver cirrhosis: 60 patients with hepatitis B (hepatitis C) viral cirrhosis were collected (using the same dose of antiviral drugs), 30 patients with hepatitis B (hepatitis C) viral cirrhosis took antiviral drugs, and 30 patients with hepatitis B (hepatitis C) virus cirrhosis were treated with sulfasalazine (0.5g three times a day) on the basis of taking antiviral drugs, and follow-up observation was observed for 12 months. 3. Treatment group of alcoholic hepatitis cirrhosis: 60 patients with alcoholic cirrhosis were collected, 30 patients with alcoholic cirrhosis did not take antifibrotic drugs, 30 cases of alcoholic cirrhosis took sulfasalazine (0.5g three times a day), and follow-up observation was observed for 12 months.

Conditions

• Cirrhosis, Liver
• Fibrosis, Liver

Interventions

Type	Name	Description
DRUG	Sulfasalazine enteric-coated tablets	Sulfasalazine enteric-coated tablets Cohort A: PBC treatment group: (1) PBC patients with poor response to UDCA after treatment: 30 patients continued to take UDCA(13-15mg/kg), 30 patients took UDCA(13-15mg/kg)+SASP (0.5g orally three times a day), 30 patients took SASP (0.5g orally three times a day) for 12 months of follow-up observation. During 12 months of treatment, at the time of enrollment and the 1st/3rd/6th/9th/12th months, the liver function, fecal flora, liver fibrosis and immune related indexes were detected. (2) Newly treated PBC patients: 30 patients took UDCA(13- 15mg/kg) and 30 patients took UDCA(13-15mg/kg)+SASP (0.5g orally three times a day) for 12 months of follow-up observation. During 12 months of treatment, at the time of enrollment and the 1st/3rd/6th/9th/12th months, the liver function, fecal flora, liver fibrosis and immune related indexes were detected.
DRUG	Sulfasalazine enteric-coated tablets	Cohort B:60 cases with hepatitis B cirrhosis were collected from each group, 30 cases continued the current treatment, and 30 patients were taking SASP (0.5g orally three times a day) for 12 months of follow-up observation. During 12 months of treatment, at the time of enrollment and the 1st/3rd/6th/9th/12th months, the liver function, fecal flora, liver fibrosis and immune related indexes were detected.
DRUG	Sulfasalazine enteric-coated tablets	Cohort C：Patients with HCV were treated with sulfasalazine Cohort C: 60 cases with hepatitis C cirrhosis were collected，30 cases continued the current treatment(people with hepatitis C cirrhosis continue to take antivirals), and30 patients were taking SASP (0.5g orally three times a day) for 12 months of follow-up observation. During 12 months of treatment, at the time of enrollment and the 1st/3rd/6th/9th/12th months, the liver function, fecal flora, liver fibrosis and immune related indexes were detected.
DRUG	Sulfasalazine enteric-coated tablets	Cohort D：Patients with alcoholic liver fibrosis/cirrhosis were treated with sulfasalazine 60 cases with alcoholic cirrhosis were collected , 30 cases continued the current treatment and 30 patients were taking SASP (0.5g orally three times a day) for 12 months of follow-up observation. During 12 months of treatment, at the time of enrollment and the 1st/3rd/6th/9th/12th months, the liver function, fecal flora, liver fibrosis and immune related indexes were detected.

Timeline

• Start date: 2024-02-01
• Primary completion: 2028-10-10
• Completion: 2028-10-10
• First posted: 2024-03-05
• Last updated: 2025-02-20

Locations

2 sites across 1 country: China