Actively Recruiting
Safety and Effectiveness of Sulfasalazine in the Treatment of Liver Fibrosis/Cirrhosis.
Led by The Second Affiliated Hospital of Chongqing Medical University · Updated on 2025-02-20
330
Participants Needed
2
Research Sites
244 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Effectiveness of Sulfasalazine in the Treatment of Liver Fibrosis/Cirrhosis.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and able to complete the study as required
- Age between 18 and 70 years
- Male weight at least 45 kg; female weight at least 40 kg
- Body mass index between 18 and 32 kg/m2
- Diagnosis of cirrhosis from one of the following: primary biliary cholangitis (PBC), hepatitis B cirrhosis, hepatitis C cirrhosis, or alcoholic cirrhosis
- For PBC patients with poor response to UDCA, biochemical criteria including ALP ≥1.67 times upper limit of normal after 12 months of UDCA treatment
- For PBC diagnosis, meeting at least two criteria: elevated alkaline phosphatase, positive anti-mitochondrial antibody or PBC-specific antibodies, or liver biopsy consistent with PBC
- Diagnosis of hepatitis B or C cirrhosis based on clinical history, histology, or imaging
- Diagnosis of alcoholic cirrhosis based on clinical history, histology, or imaging
You will not qualify if you...
- History or suspected allergy to sulfasalazine, its metabolites, sulfonamides, or salicylic acid
- Intestinal or urinary tract obstruction
- Porphyria or conditions causing acute attacks related to sulfonamides
- Liver disease caused by infections other than HBV, HCV, PBC, or alcoholic liver disease
- Primary liver cancer or other malignancies within 5 years, except fully treated tumors with no intervention in last 3 years
- Impaired gastrointestinal function or diseases affecting oral drug absorption
- 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 study
- Significant recent blood loss or transfusion
- Positive tests for AIDS, syphilis, or related infections
- History of drug dependence or abuse within 1 year
- Participation in other clinical trials within 3 months
- Positive pregnancy test during lactation or screening, or fertility requirements in past 2 years
- Other factors judged by investigator as unsuitable for participation
AI-Screening
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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
Research Team
M
Mingli Peng, Doctor
CONTACT
Y
Yinghua Lan, Doctor
CONTACT
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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