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

NARecruitingINTERVENTIONAL
Enrollment

330

Participants

Timeline

Start Date

February 1, 2024

Primary Completion Date

October 10, 2028

Study Completion Date

October 10, 2028

Conditions
Cirrhosis, LiverFibrosis, Liver
Interventions
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.

Trial Locations (2)

400000

RECRUITING

Chongqing Medical University, Chongqing

RECRUITING

Chongqing, Chongqing

All Listed Sponsors
lead

The Second Affiliated Hospital of Chongqing Medical University

OTHER