Primary biliary cholangitis: pathogenesis and therapeutic opportunities.
Aliya F Gulamhusein, Gideon M Hirschfield
https://pubmed.ncbi.nlm.nih.gov/31819247Actively Recruiting
Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID06293378
Safety and Effectiveness of Sulfasalazine in the Treatment of Liver Fibrosis and Cirrhosis
Led by The Second Affiliated Hospital of Chongqing Medical University · Updated on 2025-02-20
330
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of sulfasalazine in treating liver fibrosis and cirrhosis in patients with different types of cirrhosis, including primary biliary cirrhosis (PBC), hepatitis B and C cirrhosis, and alcoholic cirrhosis. This controlled, observational study divides patients into experimental and control groups to observe biochemical and imaging changes, liver stiffness, fecal microbiota, and metabolites over time. Participants receive treatments based on their cirrhosis type: PBC patients may continue ursodeoxycholic acid (UDCA) alone or combined with sulfasalazine; hepatitis B and C patients receive antiviral therapy with or without sulfasalazine; and alcoholic cirrhosis patients receive standard care with or without sulfasalazine. Sulfasalazine is given orally at 0.5 g three times daily for 12 months, with follow-up lasting an additional 12 months for some groups. Liver function, fecal flora, fibrosis, and immune markers are checked regularly during treatment. Participants are involved in visits at enrollment and at 1, 3, 6, 9, and 12 months during treatment, with assessments of liver fibrosis, serum liver enzyme levels, bile acids, and microbiota. These measures are repeated one month after treatment ends. The study monitors changes in liver health and gut microbiota to assess sulfasalazine’s impact, with total participation lasting up to 24 months for some groups.
CONDITIONS
Brief Title
Safety and Effectiveness of Sulfasalazine in the Treatment of Liver Fibrosis/Cirrhosis.
Who Can Participate
Age: 18Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
- Signed informed consent and ability to complete the study as required
- Age between 18 and 70 years inclusive
- Male weight not less than 45 kg, female weight not less than 40 kg
- Body mass index (BMI) between 18 and 32 kg/m2 inclusive
- Diagnosed with cirrhosis from one of the following: primary biliary cirrhosis (PBC), hepatitis B cirrhosis, hepatitis C cirrhosis, or alcoholic cirrhosis
- For PBC patients: inadequate response to UDCA with ALP 211.67 times upper limit of normal after 12 months, or newly diagnosed meeting diagnostic criteria
- Diagnosis based on clinical history, histology, or imaging relevant to cirrhosis type
You will not qualify if you...
- History of allergies or suspected allergy to the study drug or its components
- Allergy to sulfasalazine, sulfonamides, or salicylic acid
- Intestinal or urinary tract obstruction
- Porphyria or history of acute attacks caused by sulfonamides
- Acute or chronic liver disease from infections other than HBV, HCV, PBC, or alcoholic liver disease
- Primary liver cancer or other malignancies within 5 years prior to screening (except remission cases)
- Impaired gastrointestinal function affecting drug absorption, severe gastric ulcer, erosive gastritis, partial gastrectomy, or persistent severe gastrointestinal symptoms
- Serious diseases affecting circulatory, respiratory, urinary, blood, metabolic, immune, psychiatric, neurological, or renal systems
- Major trauma or surgery within 3 months before screening or planned surgery during the study
- Recent blood donation or transfusion exceeding specified volumes
- Positive for AIDS antigen/antibody, Treponema pallidum antibody, or RPR test
- History of drug dependence or abuse within 1 year prior to screening
- Participation in other clinical trials or use of investigational drugs/devices within 3 months prior to screening
- Positive pregnancy test during screening or lactation, or fertility requirements in past 2 years
- Any other factors deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 12 months
Participants receive sulfasalazine or current standard treatments for liver fibrosis/cirrhosis depending on their cohort. During the 12 months of treatment, participants will have assessments of liver function, fecal flora, liver fibrosis, and immune-related indicators.
Visits at enrollment and at months 1, 3, 6, 9, and 12 (in-person)
Follow-up
Duration - 12 months
Participants are observed for an additional 12 months after treatment to monitor ongoing effects and safety.
1 visit 1 month after treatment ends (in-person)
Trial Site Locations
Total: 2 locations
1
Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400000
Actively Recruiting
2
Chongqing
Chongqing, Chongqing Municipality, China, 400000
Actively Recruiting
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Research Team
M
Mingli Peng, Doctor
Y
Yinghua Lan, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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Published Research Related To This Trial
Regional variation and temporal trend of primary biliary cholangitis epidemiology: A systematic review and meta-analysis.
Tingting Lv, Sha Chen, Min Li...
https://pubmed.ncbi.nlm.nih.gov/33141955Primary biliary cholangitis: 2021 practice guidance update from the American Association for the Study of Liver Diseases.
Keith D Lindor, Christopher L Bowlus, James Boyer...
https://pubmed.ncbi.nlm.nih.gov/34431119