Using sulfasalazine to treat liver fibrosis and cirrhosis.

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

This study is testing if the medication sulfasalazine can help improve liver function and health in people with different types of cirrhosis.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 330 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: The Second Affiliated Hospital of Chongqing Medical University (other)
• Locations: 2 sites (Chongqing, Chongqing Municipality and 1 other locations)
• Trial ID: NCT06293378 on ClinicalTrials.gov

What this trial studies

This clinical study investigates the safety and effectiveness of sulfasalazine in treating cirrhosis across four patient cohorts: those with primary biliary cirrhosis, hepatitis B cirrhosis, hepatitis C cirrhosis, and alcoholic cirrhosis. Participants will receive sulfasalazine orally for 12 months, while a control group will not receive the medication. The study aims to observe changes in biochemical and imaging indicators, liver stiffness, fecal microbiota, and metabolites before and after treatment. The goal is to determine if sulfasalazine can improve liver function and overall health in these patients.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-70 with cirrhosis who have not responded adequately to standard treatments.

Not a fit: Patients with cirrhosis who are not within the specified age range or do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from liver fibrosis and cirrhosis.

How similar studies have performed: While the use of sulfasalazine in this context is novel, similar studies have shown promise in treating other liver conditions.

Eligibility criteria

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 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 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.

Where this trial is running

Chongqing, Chongqing Municipality and 1 other locations

• Chongqing Medical University — Chongqing, Chongqing Municipality, China (RECRUITING)
• Chongqing — Chongqing, Chongqing Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Mingli Peng, Doctor

Conditions: Cirrhosis, Liver, Fibrosis, Liver