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

Pengmingli

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, changes in fecal flora and metabolites before and after the use of sulfasalazine were observed.

2024-02-01

2028-10-10

2028-10-10

Recruiting

330

Inclusion Criteria: 1. Sign the informed consent form before the trial and be able to complete the study in accordance with the requirements of the trial protocol; 2. 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); 3. Enrolled patients also need to meet: A:Patients with PBC cirrhosis (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 for UDCA; (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:Diagnosis of hepatitis B (C) cirrhosis based on clinical history, histology or imaging. Alcoholic hepatitis cirrhosis C:Diagnosis of alcoholic cirrhosis based on clinical history, histology, or imaging. Exclusion Criteria: 1. 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; 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 acute attacks. 5. Acute and chronic liver disease with clinical significance caused by infections other than HBV, HCV, PBC, and alcoholic liver disease; 6. Primary liver cancer; alpha-fetoprotein (AFP) greater than 50 ug/L or imaging suggests malignant liver mass; Those with other malignancies or a history of other malignancies in the 5 years prior to screening (except for complete remission of malignant tumors after treatment and no additional medical or surgical intervention within 3 years prior to screening); 7. The investigator judged that there is impaired gastrointestinal function or gastrointestinal diseases that may affect the absorption of oral drugs, such as severe 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 before screening; or those who plan to undergo surgery during the study; 10. Donated blood or lost blood ≥ 400mL within 3 months before screening, or received blood transfusion; or ≥ blood donation or blood loss within 1 month prior to screening 200mL； 11. Those who are positive for AIDS antigen/antibody, positive for Treponema pallidum antibody 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 devices within 3 months before screening, and take experimental drugs or use them Those who have medical devices; 14. Those who have a positive pregnancy test during lactation or screening, or who have fertility requirements in the past two years; 15. Subjects who the investigator believes have other factors that are not suitable to participate in this trial.

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 330, 'type': 'ESTIMATED'}}

2024-05-16