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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorThe Second Affiliated Hospital of Chongqing Medical University

About this trial

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

Qualifiers

Sign the informed consent form before the trial and be able to complete the study in accordance with the requirements of the trial protocol;

The age is 18~70 years old (including boundary value), the weight of male subjects is 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 18~32kg/m2 (including critical value);

Disqualifiers

Those who have a history of allergies in the past, or the investigator suspects that they are allergic to the active ingredients of the drug or their excipients under study;

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

Patients with intestinal obstruction or urinary tract obstruction;

Patients with porphyria, such as sulfonamides, have been reported to cause acute attacks.

Trial design

Treatments tested in this trial

  • Sulfasalazine enteric-coated tablets
  • Sulfasalazine enteric-coated tablets
  • Sulfasalazine enteric-coated tablets
  • Sulfasalazine enteric-coated tablets

Treatment groups

330 Participants
are divided into 4 treatment groups