Cirrhosis, LiverNCT06293378
Safety and Effectiveness of Sulfasalazine in the Treatment of Liver Fibrosis/Cirrhosis.
A study testing Sulfasalazine enteric-coated tablets in people with Cirrhosis, Liver and Fibrosis, Liver, run by The Second Affiliated Hospital of Chongqing Medical University at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cirrhosis, Liver, Fibrosis, Liver
- What is being tested?
- Sulfasalazine enteric-coated tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 2 sitesChina
- Study dates
- 1 Feb 2024to 10 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
- 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.
Who cannot join
- 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.
- Acute and chronic liver disease with clinical significance caused by infections other than HBV, HCV, PBC, and alcoholic liver disease;
- 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);
Show all 15Show fewer
- 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);
- Serious diseases of circulatory, respiratory, urinary, blood, metabolic, immune, psychiatric, neurological, renal and other systems;
- 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;
- 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；
- Those who are positive for AIDS antigen/antibody, positive for Treponema pallidum antibody and positive RPR test;
- History of drug dependence or drug abuse within 1 year prior to screening;
- 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;
- Those who have a positive pregnancy test during lactation or screening, or who have fertility requirements in the past two years;
- Subjects who the investigator believes have other factors that are not suitable to participate in this trial.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Chongqing Medical University
Chongqing, Chongqing Municipality, 400000
Mingli Peng, Doctor, +8613512362906, Peng_mingli@hospital.cqmu.edu.cn
Yinghua Lan, Doctor, +8613796050629
- Recruiting
Chongqing
Chongqing, Chongqing Municipality, 400000
Mingli Peng, Doctor, 13512362906, 300618@cqmu.edu.cn
Yinghua Lan, Doctor, +8613796050629, 306346@hospital.cqmu.edu.cn
About this study
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.
Read the detailed description
This study is a controlled and observational clinical study initiated by the investigators to study the efficacy and safety of sulfasalazine in the treatment of cirrhosis in patients with cirrhosis, and to observe changes in patients' biochemical and imaging indicators, liver stiffness values, fecal microbiota, and metabolites before and after the use of sulfasalazine.
Four cohorts were planned to be included in this study:
Cohort A: Differences in cirrhosis changes with the addition of sulfasalazine to UDCA in PBC patients with an inadequate response to UDCA and treatment-naïve PBC patients.
Cohort B: Differences in changes in cirrhosis in patients with viral hepatitis B cirrhosis compared with the addition of sulfasalazine to antiviral (if possible, the same antiviral) therapy.
Cohort C: Differences in changes in cirrhosis in patients with viral hepatitis C cirrhosis compared with the addition of sulfasalazine to antiviral (if possible, the same antiviral) therapy.
Cohort D: Differences in differences in changes in cirrhosis compared with sulfasalazine in patients with alcoholic hepatitis cirrhosis.
Treatment options:
- Patients with PBC who did not respond adequately to UDCA: 30 patients with poor response to treated PBC continued to take UDCA, 30 patients with poor response to treated PBC received UDCA+SASP (0.5 g orally three times daily), and 30 patients with poor response received SASP (0.5 g orally three times daily) for 12 months and were followed up for 12 months. Treatment-naïve PBC patients: 30 treatment-naïve PBC patients took UDCA, and 30 treatment-naïve PBC patients took UDCA+SASP (0.5 g orally three times a day) for 12 months and followed up for 12 months.
- Treatment group of hepatitis B (hepatitis C) viral liver cirrhosis: 60 patients with hepatitis B (hepatitis C) viral cirrhosis were collected (using the same dose of antiviral drugs), 30 patients with hepatitis B (hepatitis C) viral cirrhosis took antiviral drugs, and 30 patients with hepatitis B (hepatitis C) virus cirrhosis were treated with sulfasalazine (0.5g three times a day) on the basis of taking antiviral drugs, and follow-up observation was observed for 12 months.
- Treatment group of alcoholic hepatitis cirrhosis: 60 patients with alcoholic cirrhosis were collected, 30 patients with alcoholic cirrhosis did not take antifibrotic drugs, 30 cases of alcoholic cirrhosis took sulfasalazine (0.5g three times a day), and follow-up observation was observed for 12 months.
- Conditions
- Cirrhosis, Liver, Fibrosis, Liver
- Being tested
- Sulfasalazine enteric-coated tablets
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sulfasalazine enteric-coated tabletsDrug
Sulfasalazine enteric-coated tablets Cohort A: PBC treatment group: (1) PBC patients with poor response to UDCA after treatment: 30 patients continued to take UDCA(13-15mg/kg), 30 patients took UDCA(13-15mg/kg)+SASP (0.5g orally three times a day), 30 patients took SASP (0.5g orally three times a day) for 12 months of follow-up observation. During 12 months of treatment, at the time of enrollment and the 1st/3rd/6th/9th/12th months, the liver function, fecal flora, liver fibrosis and immune related indexes were detected. (2) Newly treated PBC patients: 30 patients took UDCA(13- 15mg/kg) and 30 patients took UDCA(13-15mg/kg)+SASP (0.5g orally three times a day) for 12 months of follow-up observation. During 12 months of treatment, at the time of enrollment and the 1st/3rd/6th/9th/12th months, the liver function, fecal flora, liver fibrosis and immune related indexes were detected.
Sulfasalazine enteric-coated tabletsDrug
Cohort B:60 cases with hepatitis B cirrhosis were collected from each group, 30 cases continued the current treatment, and 30 patients were taking SASP (0.5g orally three times a day) for 12 months of follow-up observation. During 12 months of treatment, at the time of enrollment and the 1st/3rd/6th/9th/12th months, the liver function, fecal flora, liver fibrosis and immune related indexes were detected.
Sulfasalazine enteric-coated tabletsDrug
Cohort C：Patients with HCV were treated with sulfasalazine Cohort C: 60 cases with hepatitis C cirrhosis were collected，30 cases continued the current treatment(people with hepatitis C cirrhosis continue to take antivirals), and30 patients were taking SASP (0.5g orally three times a day) for 12 months of follow-up observation. During 12 months of treatment, at the time of enrollment and the 1st/3rd/6th/9th/12th months, the liver function, fecal flora, liver fibrosis and immune related indexes were detected.
Sulfasalazine enteric-coated tabletsDrug
Cohort D：Patients with alcoholic liver fibrosis/cirrhosis were treated with sulfasalazine 60 cases with alcoholic cirrhosis were collected , 30 cases continued the current treatment and 30 patients were taking SASP (0.5g orally three times a day) for 12 months of follow-up observation. During 12 months of treatment, at the time of enrollment and the 1st/3rd/6th/9th/12th months, the liver function, fecal flora, liver fibrosis and immune related indexes were detected.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A：Patients with PBC were treated with sulfasalazine | Experimental | PBC treatment group:
1. PBC patients with poor response to UDCA after treatment: 30 patients continued to take UDCA 13-15mg/kg , 30 patients took UDCA 13-15mg/kg +SASP (0.5g orally three times a day), 30 patients took SASP (0.5g orally three times a day) for 12 months of follow-up observation. During 12 months of treatment, at the time of enrollment and the 1st/3rd/6th/9th/12th months, the liver function, fecal flora, liver fibrosis and immune related indexes were detected.
2. Newly treated PBC patients: 30 patients took UDCA 13-15mg/kg and 30 patients took UDCA 13-15mg/kg +SASP (0.5g orally three times a day) for 12 months of follow-up observation. During 12 months of treatment, at the time of enrollment and the 1st/3rd/6th/9th/12th months, the liver function, fecal flora, liver fibrosis and immune related indexes were detected. Receives: Drug: Sulfasalazine enteric-coated tablets |
| Cohort B：Patients with HBV were treated with sulfasalazine | Experimental | Cohort B: 60 cases with hepatitis B cirrhosis were collected , 30 cases continued the current treatment(people with hepatitis B cirrhosis continue to take antivirals), and 30 patients were taking sulfasalazine for 12 months of follow-up observation. During 12 months of treatment, at the time of enrollment and the 1st/3rd/6th/9th/12th months, the liver function, fecal flora, liver fibrosis and immune related indexes were detected. Receives: Drug: Sulfasalazine enteric-coated tablets |
| Cohort C：Patients with HCV were treated with sulfasalazine | Experimental | Cohort C: 60 cases with hepatitis C cirrhosis were collected，30 cases continued the current treatment(people with hepatitis C cirrhosis continue to take antivirals), and30 patients were taking sulfasalazine for 12 months of follow-up observation. During 12 months of treatment, at the time of enrollment and the 1st/3rd/6th/9th/12th months, the liver function, fecal flora, liver fibrosis and immune related indexes were detected. Receives: Drug: Sulfasalazine enteric-coated tablets |
| Cohort D：Patients with alcoholic liver fibrosis/cirrhosis were treated with sulfasalazine | Experimental | 60 cases with alcoholic cirrhosis were collected , 30 cases continued the current treatment and 30 patients were taking sulfasalazine for 12 months of follow-up observation. During 12 months of treatment at the time of enrollment and the 1st/3rd/6th/9th/12th months, the liver function, fecal flora, liver fibrosis and immune related indexes were detected. Receives: Drug: Sulfasalazine enteric-coated tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatic fibrosis
The changes of liver fibrosis
Measured: baseline，1,3,6,9,12 months after treatment and 1 month after the end of treatment.
Serum alkaline phosphatase (ALP)
Serum alkaline phosphatase (ALP) level
Measured: baseline,1,3,6,9,12 months after treatment and 1 month after the end of treatment.
Serum γ-glutamyl transpeptidase (GGT)
Serum γ-glutamyl transpeptidase (GGT) level
Measured: baseline,1,3,6,9,12 months after treatment and 1 month after the end of treatment.
Serum bilirubin
Serum bilirubin level
Measured: baseline,1,3,6,9,12 months after treatment and 1 month after the end of treatment.
Serum bile acids
Serum bile acids level
Measured: baseline,1,3,6,9,12 months after treatment and 1 month after the end of treatment.
Serum aspartate aminotransferase(AST)
Serum aspartate aminotransferase(AST) level
Measured: baseline,1,3,6,9,12 months after treatment and 1 month after the end of treatment.
Serum alanine aminotransferase (ALT)
Serum alanine aminotransferase (ALT) level
Measured: baseline,1,3,6,9,12 months after treatment and 1 month after the end of treatment.
Secondary outcomes (1)
The gut microbiota and metabolites.
The levels of changes in gut microbiota and metabolites.
Measured: baseline,1,3,6,9,12 months after treatment and 1 month after the end of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start1 Feb 2024
- Primary completion10 Oct 2028 (estimated)
- Study completion10 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cirrhosis, LiverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mingli Peng, Doctor, Study chair, The Second Affiliated Hospital of Chongqing Medical UniversityYinghua Lan, Doctor, Study chair, Doctor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06293378
- Sponsor's protocol ID
- Pengmingli
- Status last verified
- Feb 2025
- First submitted
- 17 Jan 2024
- Last updated
- 20 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gulamhusein AF, Hirschfield GM. Primary biliary cholangitis: pathogenesis and therapeutic opportunities. Nat Rev Gastroenterol Hepatol. 2020 Feb;17(2):93-110. doi: 10.1038/s41575-019-0226-7. Epub 2019 Dec 9.
PubMed 31819247Lv T, Chen S, Li M, Zhang D, Kong Y, Jia J. Regional variation and temporal trend of primary biliary cholangitis epidemiology: A systematic review and meta-analysis. J Gastroenterol Hepatol. 2021 Jun;36(6):1423-1434. doi: 10.1111/jgh.15329. Epub 2020 Dec 6.
PubMed 33141955Lindor KD, Bowlus CL, Boyer J, Levy C, Mayo M. Primary biliary cholangitis: 2021 practice guidance update from the American Association for the Study of Liver Diseases. Hepatology. 2022 Apr;75(4):1012-1013. doi: 10.1002/hep.32117. Epub 2021 Dec 20. No abstract available.
PubMed 34431119
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of Sulfasalazine in the Treatment of Liver Fibrosis/Cirrhosis.
- ClinicalTrials.gov ID
- NCT06293378
- Acronym / sponsor ID
- Pengmingli
- Conditions
- Cirrhosis, Liver, Fibrosis, Liver
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 10 Oct 2028 (estimated)
- Study completion
- 10 Oct 2028 (estimated)
- First posted
- 5 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a controlled and observational clinical study initiated by the investigators to study the efficacy and safety of sulfasalazine in the treatment of cirrhosis in patients with cirrhosis, and to observe changes in patients' biochemical and imaging indicators, liver stiffness values, fecal microbiota, and metabolites before and after the use of sulfasalazine.
Four cohorts were planned to be included in this study:
Cohort A: Differences in cirrhosis changes with the addition of sulfasalazine to UDCA in PBC patients with an inadequate response to UDCA and treatment-naïve PBC patients.
Cohort B: Differences in changes in cirrhosis in patients with viral hepatitis B cirrhosis compared with the addition of sulfasalazine to antiviral (if possible, the same antiviral) therapy.
Cohort C: Differences in changes in cirrhosis in patients with viral hepatitis C cirrhosis compared with the addition of sulfasalazine to antiviral (if possible, the same antiviral) therapy.
Cohort D: Differences in differences in changes in cirrhosis compared with sulfasalazine in patients with alcoholic hepatitis cirrhosis.
Treatment options:
- Patients with PBC who did not respond adequately to UDCA: 30 patients with poor response to treated PBC continued to take UDCA, 30 patients with poor response to treated PBC received UDCA+SASP (0.5 g orally three times daily), and 30 patients with poor response received SASP (0.5 g orally three times daily) for 12 months and were followed up for 12 months. Treatment-naïve PBC patients: 30 treatment-naïve PBC patients took UDCA, and 30 treatment-naïve PBC patients took UDCA+SASP (0.5 g orally three times a day) for 12 months and followed up for 12 months.
- Treatment group of hepatitis B (hepatitis C) viral liver cirrhosis: 60 patients with hepatitis B (hepatitis C) viral cirrhosis were collected (using the same dose of antiviral drugs), 30 patients with hepatitis B (hepatitis C) viral cirrhosis took antiviral drugs, and 30 patients with hepatitis B (hepatitis C) virus cirrhosis were treated with sulfasalazine (0.5g three times a day) on the basis of taking antiviral drugs, and follow-up observation was observed for 12 months.
- Treatment group of alcoholic hepatitis cirrhosis: 60 patients with alcoholic cirrhosis were collected, 30 patients with alcoholic cirrhosis did not take antifibrotic drugs, 30 cases of alcoholic cirrhosis took sulfasalazine (0.5g three times a day), and follow-up observation was observed for 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort A：Patients with PBC were treated with sulfasalazine | Experimental | Drug: Sulfasalazine enteric-coated tabletsPBC treatment group: 1. PBC patients with poor response to UDCA after treatment: 30 patients continued to take UDCA 13-15mg/kg , 30 patients took UDCA 13-15mg/kg +SASP (0.5g orally three times a day), 30 patients took SASP (0.5g orally three times a day) for 12 months of follow-up observation. During 12 months of treatment, at the time of enrollment and the 1st/3rd/6th/9th/12th months, the liver function, fecal flora, liver fibrosis and immune related indexes were detected. 2. Newly treated PBC patients: 30 patients took UDCA 13-15mg/kg and 30 patients took UDCA 13-15mg/kg +SASP (0.5g orally three times a day) for 12 months of follow-up observation. During 12 months of treatment, at the time of enrollment and the 1st/3rd/6th/9th/12th months, the liver function, fecal flora, liver fibrosis and immune related indexes were detected. |
| Cohort B：Patients with HBV were treated with sulfasalazine | Experimental | Drug: Sulfasalazine enteric-coated tabletsCohort B: 60 cases with hepatitis B cirrhosis were collected , 30 cases continued the current treatment(people with hepatitis B cirrhosis continue to take antivirals), and 30 patients were taking sulfasalazine for 12 months of follow-up observation. During 12 months of treatment, at the time of enrollment and the 1st/3rd/6th/9th/12th months, the liver function, fecal flora, liver fibrosis and immune related indexes were detected. |
| Cohort C：Patients with HCV were treated with sulfasalazine | Experimental | Drug: Sulfasalazine enteric-coated tabletsCohort C: 60 cases with hepatitis C cirrhosis were collected，30 cases continued the current treatment(people with hepatitis C cirrhosis continue to take antivirals), and30 patients were taking sulfasalazine for 12 months of follow-up observation. During 12 months of treatment, at the time of enrollment and the 1st/3rd/6th/9th/12th months, the liver function, fecal flora, liver fibrosis and immune related indexes were detected. |
| Cohort D：Patients with alcoholic liver fibrosis/cirrhosis were treated with sulfasalazine | Experimental | Drug: Sulfasalazine enteric-coated tablets60 cases with alcoholic cirrhosis were collected , 30 cases continued the current treatment and 30 patients were taking sulfasalazine for 12 months of follow-up observation. During 12 months of treatment at the time of enrollment and the 1st/3rd/6th/9th/12th months, the liver function, fecal flora, liver fibrosis and immune related indexes were detected. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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);
- 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.
Key exclusion criteria (15 listed)
- 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.
- Acute and chronic liver disease with clinical significance caused by infections other than HBV, HCV, PBC, and alcoholic liver disease;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sulfasalazine enteric-coated tabletsSulfasalazine enteric-coated tablets Cohort A: PBC treatment group: (1) PBC patients with poor response to UDCA after treatment: 30 patients continued to take UDCA(13-15mg/kg), 30 patients took UDCA(13-15mg/kg)+SASP (0.5g orally three times a day), 30 patients took SASP (0.5g orally three times a day) for 12 months of follow-up observation. During 12 months of treatment, at the time of enrollment and the 1st/3rd/6th/9th/12th months, the liver function, fecal flora, liver fibrosis and immune related indexes were detected. (2) Newly treated PBC patients: 30 patients took UDCA(13- 15mg/kg) and 30 patients took UDCA(13-15mg/kg)+SASP (0.5g orally three times a day) for 12 months of follow-up observation. During 12 months of treatment, at the time of enrollment and the 1st/3rd/6th/9th/12th months, the liver function, fecal flora, liver fibrosis and immune related indexes were detected. | Drug | Cohort A：Patients with PBC were treated with sulfasalazine |
| Sulfasalazine enteric-coated tabletsCohort B:60 cases with hepatitis B cirrhosis were collected from each group, 30 cases continued the current treatment, and 30 patients were taking SASP (0.5g orally three times a day) for 12 months of follow-up observation. During 12 months of treatment, at the time of enrollment and the 1st/3rd/6th/9th/12th months, the liver function, fecal flora, liver fibrosis and immune related indexes were detected. | Drug | Cohort B：Patients with HBV were treated with sulfasalazine |
| Sulfasalazine enteric-coated tabletsCohort C：Patients with HCV were treated with sulfasalazine Cohort C: 60 cases with hepatitis C cirrhosis were collected，30 cases continued the current treatment(people with hepatitis C cirrhosis continue to take antivirals), and30 patients were taking SASP (0.5g orally three times a day) for 12 months of follow-up observation. During 12 months of treatment, at the time of enrollment and the 1st/3rd/6th/9th/12th months, the liver function, fecal flora, liver fibrosis and immune related indexes were detected. | Drug | Cohort C：Patients with HCV were treated with sulfasalazine |
| Sulfasalazine enteric-coated tabletsCohort D：Patients with alcoholic liver fibrosis/cirrhosis were treated with sulfasalazine 60 cases with alcoholic cirrhosis were collected , 30 cases continued the current treatment and 30 patients were taking SASP (0.5g orally three times a day) for 12 months of follow-up observation. During 12 months of treatment, at the time of enrollment and the 1st/3rd/6th/9th/12th months, the liver function, fecal flora, liver fibrosis and immune related indexes were detected. | Drug | Cohort D：Patients with alcoholic liver fibrosis/cirrhosis were treated with sulfasalazine |
Primary outcome
Hepatic fibrosis
Time frame: baseline，1,3,6,9,12 months after treatment and 1 month after the end of treatment.
The changes of liver fibrosis
Serum alkaline phosphatase (ALP)
Time frame: baseline,1,3,6,9,12 months after treatment and 1 month after the end of treatment.
Serum alkaline phosphatase (ALP) level
Serum γ-glutamyl transpeptidase (GGT)
Time frame: baseline,1,3,6,9,12 months after treatment and 1 month after the end of treatment.
Serum γ-glutamyl transpeptidase (GGT) level
Serum bilirubin
Time frame: baseline,1,3,6,9,12 months after treatment and 1 month after the end of treatment.
Serum bilirubin level
Serum bile acids
Time frame: baseline,1,3,6,9,12 months after treatment and 1 month after the end of treatment.
Serum bile acids level
Serum aspartate aminotransferase(AST)
Time frame: baseline,1,3,6,9,12 months after treatment and 1 month after the end of treatment.
Serum aspartate aminotransferase(AST) level
Serum alanine aminotransferase (ALT)
Time frame: baseline,1,3,6,9,12 months after treatment and 1 month after the end of treatment.
Serum alanine aminotransferase (ALT) level
1 secondary outcome
The gut microbiota and metabolites.
Time frame: baseline,1,3,6,9,12 months after treatment and 1 month after the end of treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Results publication: PubMed 31819247Gulamhusein AF, Hirschfield GM. Primary biliary cholangitis: pathogenesis and therapeutic opportunities. Nat Rev Gastroenterol Hepatol. 2020 Feb;17(2):93-110. doi: 10.1038/s41575-019-0226-7. Epub 2019 Dec 9.
- Results publication: PubMed 33141955Lv T, Chen S, Li M, Zhang D, Kong Y, Jia J. Regional variation and temporal trend of primary biliary cholangitis epidemiology: A systematic review and meta-analysis. J Gastroenterol Hepatol. 2021 Jun;36(6):1423-1434. doi: 10.1111/jgh.15329. Epub 2020 Dec 6.
- Results publication: PubMed 34431119Lindor KD, Bowlus CL, Boyer J, Levy C, Mayo M. Primary biliary cholangitis: 2021 practice guidance update from the American Association for the Study of Liver Diseases. Hepatology. 2022 Apr;75(4):1012-1013. doi: 10.1002/hep.32117. Epub 2021 Dec 20. No abstract available.
- Individual participant dataSharing planned: No
Related trials for Cirrhosis, Liver
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
Recruiting
CirrhosisRx CDS System
Cirrhosis, Decision Support Systems, Clinical
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mingli Peng, Doctor study chair
The Second Affiliated Hospital of Chongqing Medical University
Yinghua Lan, Doctor study chair
Doctor
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sulfasalazine enteric-coated tablets in people with Cirrhosis, Liver and Fibrosis, Liver, run by The Second Affiliated Hospital of Chongqing Medical University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mingli Peng, Doctor (+8613512362906, 300618@cqmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hepatic fibrosis (time frame: baseline，1,3,6,9,12 months after treatment and 1 month after the end of treatment.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06293378, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.