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

Last updated: February 18, 2025
Sponsor: The Second Affiliated Hospital of Chongqing Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Scar Tissue

Hyponatremia

Hepatic Fibrosis

Treatment

Sulfasalazine enteric-coated tablets

Clinical Study ID

NCT06293378
Pengmingli
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Sign the informed consent form before the trial and be able to complete the study inaccordance with the requirements of the trial protocol;

  2. The age is 1870 years old (including boundary value), the weight of male subjectsis not less than 45 kg, and the weight of female subjects is not less than 40 kg.Body mass index (BMI) in the range of 1832kg/m2 (including critical value);

  3. Enrolled patients also need to meet:

A:Patients with PBC cirrhosis PBC patients who have been treated and show an inadequate response to UDCA:(1) according to the biochemical response criteria for 2021 PBC, Enrolled patients need to meet the criteria of ALP ≥1.67 × ULN as a poor biochemical response to UDCA after 12 months of UDCA treatment; (2) meeting the diagnostic criteria for primary cholangitis (PBC) , i.e. meeting at least two of the following criteria: 1.indicators of cholestasis such as elevated Alkaline phosphatase; 2.Anti-mitochondrial antibody AMA or AMA-m2 positive, or if AMA negative, PBC-specific antibodies (anti-GP210 Andor anti-SP100) positive .3 liver biopsy consistent with PBC; Patients with newly diagnosed primary cholangitis (PBC-RRB- met the diagnostic criteria of at least two of the following): 1.indicators of cholestasis such as elevated Alkaline phosphatase; 2.Anti-mitochondrial antibody AMA or AMA-m2 positive, or if AMA negative, PBC-specific antibodies (anti-GP210 Andor anti-SP100) positive 3. liver biopsy consistent with PBC; B:Patients with hepatitis B cirrhosis Diagnosis of hepatitis B cirrhosis based on clinical history, histology or imaging.

C:Patients with hepatitis C cirrhosis Diagnosis of hepatitis C cirrhosis based on clinical history, histology or imaging.

D:Alcoholic hepatitis cirrhosis Diagnosis of alcoholic cirrhosis based on clinical history, histology, or imaging.

Exclusion

Exclusion Criteria:

  1. Those who have a history of allergies in the past, or the investigator suspects thatthey are allergic to the active ingredients of the drug or their excipients understudy;

  2. Allergy to sulfasalazine and its metabolites, sulfonamides or salicylic acid;

  3. Patients with intestinal obstruction or urinary tract obstruction;

  4. Patients with porphyria, such as sulfonamides, have been reported to cause acuteattacks.

  5. Acute and chronic liver disease with clinical significance caused by infectionsother than HBV, HCV, PBC, and alcoholic liver disease;

  6. Primary liver cancer; alpha-fetoprotein (AFP) greater than 50 ug/L or imagingsuggests malignant liver mass; Those with other malignancies or a history of othermalignancies in the 5 years prior to screening (except for complete remission ofmalignant tumors after treatment and no additional medical or surgical interventionwithin 3 years prior to screening);

  7. The investigator judged that there is impaired gastrointestinal function orgastrointestinal diseases that may affect the absorption of oral drugs, such assevere gastric ulcer, erosive gastritis, partial gastrectomy, and persistent >Grade 2 gastrointestinal symptoms (e.g., nausea, vomiting, or diarrhoea);

  8. Serious diseases of circulatory, respiratory, urinary, blood, metabolic, immune,psychiatric, neurological, renal and other systems;

  9. Those who have had major trauma or undergone major surgery within 3 months beforescreening; or those who plan to undergo surgery during the study;

  10. Donated blood or lost blood ≥ 400mL within 3 months before screening, or receivedblood transfusion; or ≥ blood donation or blood loss within 1 month prior toscreening 200mL;

  11. Those who are positive for AIDS antigen/antibody, positive for Treponema pallidumantibody and positive RPR test;

  12. History of drug dependence or drug abuse within 1 year prior to screening;

  13. Participate in clinical trials of other investigational drugs or medical deviceswithin 3 months before screening, and take experimental drugs or use them Those whohave medical devices;

  14. Those who have a positive pregnancy test during lactation or screening, or who havefertility requirements in the past two years;

  15. Subjects who the investigator believes have other factors that are not suitable toparticipate in this trial.

Study Design

Total Participants: 330
Treatment Group(s): 1
Primary Treatment: Sulfasalazine enteric-coated tablets
Phase:
Study Start date:
February 01, 2024
Estimated Completion Date:
October 10, 2028

Study 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.

Connect with a study center

  • Chongqing

    Chongqing, Chongqing 400000
    China

    Active - Recruiting

  • Chongqing Medical University

    Chongqing, Chongqing 400000
    China

    Active - Recruiting

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